Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03199885
Other study ID # NCI-2017-01119
Secondary ID NCI-2017-01119NR
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 5, 2019
Est. completion date May 15, 2025

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic). Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of "targeted therapy" because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body's immune system. Monoclonal antibodies, such as pertuzumab, may interfere with the ability of cancer cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab may kill more tumor cells. *NOTE: This study has a central confirmation step. The purpose of this step is to confirm by central testing that the patient's tumor has specific receptors. If the patient meets all the study requirements, the patient will join the study and begin therapy for breast cancer while the tumor is being tested.


Description:

PRIMARY OBJECTIVE: I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the progression-free survival (PFS), assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, relative to the addition of a placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) in patients with newly documented HER2-positive measurable metastatic breast cancer. SECONDARY OBJECTIVES: I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the overall survival (OS) relative to the addition of placebo to a regimen of pertuzumab and trastuzumab, combined with a taxane (paclitaxel or docetaxel). II. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will improve the overall objective response (OR) in the cohort of patients randomized 6 months or more prior to study accrual closure assessed by investigator using RECIST 1.1 criteria, relative to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel). III. To determine the immune-related toxicity profile of the two treatment regimens. IV. To determine the cardiac safety profile of the two treatment regimens. EXPLORATORY OBJECTIVES: I. To determine whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to the addition of a placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel). II. To determine the utility of PD-L1 immunohistochemistry (IHC) staining as a predictive and prognostic biomarker associated with clinical response, as assessed by investigator using RECIST 1.1 criteria, to atezolizumab in combination with trastuzumab and pertuzumab combined with a taxane (paclitaxel or docetaxel). III. To identify potential biomarkers that can predict benefit from the addition of atezolizumab in patients with newly documented HER2-positive measurable metastatic breast cancer treated with a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel). IV. To explore the toxicity profile of the two treatment regimens using patient-reported symptomatic adverse events in addition to standard adverse event reports. V. To determine the feasibility and added value of frequent assessment of toxicity using Patient Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) with electronic(e)PRO reporting. VI. To explore whether the addition of atezolizumab to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel) will contribute to increased patient-reported fatigue in comparison to the addition of placebo to a regimen of pertuzumab and trastuzumab combined with a taxane (paclitaxel or docetaxel). OUTLINE: STEP 1: Patients receive pertuzumab intravenously (IV) over 30-60 minutes on days 1 and 22, trastuzumab IV over 30-90 minutes on days 1 and 22, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 or docetaxel IV over 60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo a biopsy at baseline. Patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and/or bone scan at baseline. STEP 2: Patients are randomized to 1 of 2 arms. ARM I: Patients receive pertuzumab IV over 30-60 minutes on days 1 and 22 of each cycle, trastuzumab IV over 30-90 minutes on days 1 and 22 of each cycle, and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, 29, and 36 of each cycle or docetaxel IV over 60 minutes on days 1 and 22 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5. ARM II: Patients receive pertuzumab, trastuzumab, and paclitaxel or docetaxel as in Arm I. Patients also receive placebo IV 30-60 minutes on day 22 of cycle 1 and days 1 and 22 of subsequent cycles. Cycles repeat every 6 weeks for 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT or MRI at baseline, prior to weeks 10, 19, 28 and then at 9, 12, 15, 18, 21, and 24 months from study entry, every 3 months through year 3, every 6 months for years 4 and 5, and then every 6 months for years 6 through 10 from study entry. Patients undergo a bone scan at baseline, every 6 months from study entry, every 6 months through year 3, and every 12 months for years 4 and 5. After completion of study treatment, patients are followed up at 30 days and every 3 months for 3 years and then every 6 months for 5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 190
Est. completion date May 15, 2025
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines - The trial is open to female and male patients - Patients must be >= 18 years old - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease outside the central nervous system (CNS) confirmed as described below; eligible patients include those with either: - De novo metastatic disease presenting without prior history of HER2-positive breast cancer: - Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient - Locally recurrent or metastatic disease following prior therapy for early breast cancer: - Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease - There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy - Patients must have measurable disease based on RECIST 1.1, as determined by the site, which has not been irradiated to be eligible - Patients with brain metastases are eligible if they meet ALL the following criteria: - Four or fewer metastatic sites to CNS - Largest unexcised tumor does not exceed 3 cm - No metastases to brain stem, midbrain, pons, medulla or the optic nerves and chiasm - Must have measurable disease outside the CNS, based on RECIST 1.1, as determined by the site, which has not been irradiated - If patient presented with symptoms from CNS metastases, the symptoms must have resolved with initiation of steroids and initial local therapy (surgery, radiation therapy, or both) - Must have been evaluated by Medical Oncologist and plan is to administer trastuzumab, pertuzumab, and a taxane as first-line systemic therapy - May have received administration of trastuzumab OR lapatinib concurrently with radiation therapy for brain metastases. Toxicities related to lapatinib if administered, should be =< grade 1 per the CTCAE v5.0, and the lapatinib must have been completed at least 2 weeks prior to study entry - No history of intracranial hemorrhage or spinal cord hemorrhage - No neurosurgical resection or brain biopsy within 10 days prior to study entry - After study entry and before randomization, send tissue for central HER2 confirmation; a tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on local testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status should initially be assessed using an Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; Note: Once HER2-positive is confirmed on central testing, patients will be randomized to atezolizumab/placebo; randomization within 14 days from study entry will ensure that the Pharmaceutical Management Branch (PMB)-supplied agents will be received at the site for treatment on day 22 of cycle 1 - The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant - The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with < 1% ER and PgR staining by IHC will be classified as negative; if enough material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility - Localized palliative radiation therapy to sites of non-measurable disease is allowed for symptom management and may begin prior to study entry and continue following study entry while receiving study therapy - Patients must have imaging of the chest/abdomen/pelvis, preferably with a CT scan, and a bone scan within 5 weeks prior to study entry; (NOTE: if a patient is unable to receive CT contrast, a MRI of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative) - MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients - Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 14 days prior to study entry) - Platelet count must be >= 100,000/mm^3 (within 14 days prior to study entry) - Hemoglobin must be >= 8 g/dL (within 14 days prior to study entry) - Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to study entry) - Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases (within 14 days prior to study entry) - Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to study entry) - Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to study entry; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility - A serum thyroid-stimulating hormone (TSH) and AM (preferably in morning) cortisol must be obtained within 14 days prior to study entry to obtain a baseline value; patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards; asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologist's recommendations are eligible - Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to study entry; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal - Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of study entry are eligible for this trial Exclusion Criteria: - Patients with brain metastases are excluded if they meet ANY of the following criteria: - Symptoms from brain metastases have not resolved prior to study entry - Five or more clearly identified foci of metastases to the brain - Largest unexcised tumor exceeds 3 cm - Spinal cord metastases - Medical Oncologist plans to employ HER2-directed tyrosine kinase inhibitor as component of systemic therapy - Metastatic disease limited to CNS - Leptomeningeal carcinomatosis - History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) except as described in inclusion criteria - History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent - Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease - Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies - History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry - Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria) - History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy even if the current LVEF is >= 50% - Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to: - Active cardiac disease - Angina pectoris that requires the current use of anti-anginal medication; - Ventricular arrhythmias except for benign premature ventricular contractions; - Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; - Conduction abnormality requiring a pacemaker; - Valvular disease with documented compromise in cardiac function; or - Symptomatic pericarditis - History of cardiac disease - Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function; - History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or - Documented cardiomyopathy - Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the CTCAE v 5.0 - History of severe allergic, anaphylactic, or other hypersensitivity reactions to pertuzumab or trastuzumab or to any of its excipients, as well as any chimeric or humanized antibodies or fusion proteins - Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies - Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL, polysorbate 80) - History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis - Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible - Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible - Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: - Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations - Rash must cover less than 10% of body surface area (BSA) - Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%) - No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) - Treatment with systemic immunomodulatory medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to study entry - Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to study entry or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed - Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to study entry - Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines - Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA) - Patients with clinically active tuberculosis - Severe infection within 4 weeks prior to study entry, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia - Prior allogeneic stem cell or solid organ transplantation - Symptomatic peripheral ischemia - History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or >= grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan - Administration of a live, attenuated vaccine within 4 weeks prior to study entry or anticipation that such vaccine will be required during the study - Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to study entry, during treatment or within 5 months following the last dose of atezolizumab/placebo - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications - Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results - Pregnancy or lactation at the time of study entry or intention to become pregnant during the study; (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 3 days prior to study entry) - Use of any investigational product within 4 weeks prior to study entry

Study Design


Intervention

Drug:
Atezolizumab
Given IV
Procedure:
Biopsy
Undergo biopsy
Bone Scan
Undergo bone scan
Computed Tomography
Undergo CT scan
Drug:
Docetaxel
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Drug:
Paclitaxel
Given IV
Biological:
Pertuzumab
Given IV
Other:
Placebo Administration
Given IV
Quality-of-Life Assessment
Ancillary studies
Biological:
Trastuzumab
Given IV

Locations

Country Name City State
Canada William Osler Health System-Brampton Civic Hospital Brampton Ontario
Canada Cross Cancer Institute Edmonton Alberta
Canada CSSS Champlain-Charles Le Moyne Greenfield Park Quebec
Canada London Regional Cancer Program London Ontario
Canada The Moncton Hospital Moncton New Brunswick
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Algoma District Cancer Program Sault Area Hospital Sault Ste Marie Ontario
Canada Doctor H. Bliss Murphy Cancer Centre St. John's Newfoundland and Labrador
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
Canada BCCA-Vancouver Island Cancer Centre Victoria British Columbia
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Summa Health System - Akron Campus Akron Ohio
United States Phoebe Putney Memorial Hospital Albany Georgia
United States Atrium Health Stanly/LCI-Albemarle Albemarle North Carolina
United States New Mexico Oncology Hematology Consultants Albuquerque New Mexico
United States Presbyterian Kaseman Hospital Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States AdventHealth Altamonte Altamonte Springs Florida
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Kaiser Permanente-Anaheim Anaheim California
United States Katmai Oncology Group Anchorage Alaska
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Kaiser Permanente-Deer Valley Medical Center Antioch California
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Randolph Hospital Asheboro North Carolina
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Hope Women's Cancer Centers-Asheville Asheville North Carolina
United States Messino Cancer Centers Asheville North Carolina
United States Mission Hospital Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States University Cancer and Blood Center LLC Athens Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Augusta Oncology Associates PC-D'Antignac Augusta Georgia
United States Augusta Oncology Associates PC-Wheeler Augusta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States UCHealth University of Colorado Hospital Aurora Colorado
United States GenesisCare USA - Aventura FP Aventura Florida
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Greater Baltimore Medical Center Baltimore Maryland
United States Kaiser Permanente-Woodlawn Medical Center Baltimore Maryland
United States Saint Agnes Hospital Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Summa Health System - Barberton Campus Barberton Ohio
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Our Lady of the Lake Medical Oncology Baton Rouge Louisiana
United States Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States Woman's Hospital Baton Rouge Louisiana
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States UM Upper Chesapeake Medical Center Bel Air Maryland
United States Waldo County General Hospital Belfast Maine
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Beverly Hospital Beverly Massachusetts
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Billings Clinic Cancer Center Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph's/Candler - Bluffton Campus Bluffton South Carolina
United States GenesisCare USA - Boca Ration FP06 Boca Raton Florida
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States United Hospital Center Bridgeport West Virginia
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Crozer-Keystone Regional Cancer Center at Broomall Broomall Pennsylvania
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Roswell Park Cancer Institute Buffalo New York
United States Kaiser Permanente-Burke Medical Center Burke Virginia
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Cone Health Cancer Center at Alamance Regional Burlington North Carolina
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Fairview Ridges Hospital Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cooper Hospital University Medical Center Camden New Jersey
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States Illinois CancerCare-Carthage Carthage Illinois
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States AdventHealth Celebration Celebration Florida
United States Geauga Hospital Chardon Ohio
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Atrium Health Pineville/LCI-Pineville Charlotte North Carolina
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Chelsea Hospital Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States McLaren Cancer Institute-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Main Line Health Center-Collegeville Collegeville Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Memorial Hospital North Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States Memorial Sloan Kettering Commack Commack New York
United States Atrium Health Cabarrus/LCI-Concord Concord North Carolina
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Cookeville Regional Medical Center Cookeville Tennessee
United States Mercy Hospital Coon Rapids Minnesota
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States UC Irvine Health Cancer Center-Newport Costa Mesa California
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Northwest Cancer Center - Main Campus Crown Point Indiana
United States AMG Crystal Lake - Oncology Crystal Lake Illinois
United States Danbury Hospital Danbury Connecticut
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Cancer Center of Colorado at Sloan's Lake Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States City of Hope Comprehensive Cancer Center Duarte California
United States Kaiser Permanente Dublin Dublin California
United States Essentia Health Cancer Center Duluth Minnesota
United States Northside Hospital - Duluth Duluth Georgia
United States Northwest Oncology LLC Dyer Indiana
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States University of Maryland Shore Medical Center at Easton Easton Maryland
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin
United States Saint Elizabeth Healthcare Edgewood Edgewood Kentucky
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Mercy Cancer Center-Elyria Elyria Ohio
United States Saint Vincent Hospital Erie Pennsylvania
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Exeter Hospital Exeter New Hampshire
United States Main Line Health Center-Exton Exton Pennsylvania
United States Inova Schar Cancer Institute Fairfax Virginia
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Weisberg Cancer Treatment Center Farmington Hills Michigan
United States Piedmont Fayette Hospital Fayetteville Georgia
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States McLaren Cancer Institute-Flint Flint Michigan
United States Singh and Arora Hematology Oncology PC Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Eisenhower Army Medical Center Fort Gordon Georgia
United States Broward Health Medical Center Fort Lauderdale Florida
United States Holy Cross Hospital Fort Lauderdale Florida
United States Beebe South Coastal Health Campus Frankford Delaware
United States FMH James M Stockman Cancer Institute Frederick Maryland
United States Kaiser Permanente-Fremont Fremont California
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Washington Hospital Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Kaiser Permanente-Gaithersburg Medical Center Gaithersburg Maryland
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Levine Cancer Institute-Gaston Gastonia North Carolina
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States Crozer Regional Cancer Center at Brinton Lake Glen Mills Pennsylvania
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States CTCA at Western Regional Medical Center Goodyear Arizona
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States UCHealth Greeley Hospital Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Cone Health Cancer Center Greensboro North Carolina
United States UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg Pennsylvania
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
United States Gulfport Memorial Hospital Gulfport Mississippi
United States Hackensack University Medical Center Hackensack New Jersey
United States Kaiser Permanente - Harbor City Harbor City California
United States UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg Pennsylvania
United States Memorial Sloan Kettering Westchester Harrison New York
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Ingalls Memorial Hospital Harvey Illinois
United States HaysMed Hays Kansas
United States Advocate South Suburban Hospital Hazel Crest Illinois
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States South Carolina Cancer Specialists PC Hilton Head Island South Carolina
United States Northwest Cancer Center - Hobart Hobart Indiana
United States Saint Mary Medical Center Hobart Indiana
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kaiser Permanente Moanalua Medical Center Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States Oncology Center of The South Incorporated Houma Louisiana
United States Houston Methodist Hospital Houston Texas
United States M D Anderson Cancer Center Houston Texas
United States Saint Catherine Hospital Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Kaiser Permanente-Irvine Irvine California
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States McFarland Clinic - Jefferson Jefferson Iowa
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Jefferson Hospital Jefferson Hills Pennsylvania
United States University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek Wisconsin
United States UPMC-Johnstown/John P. Murtha Regional Cancer Center Johnstown Pennsylvania
United States Duly Health and Care Joliet Joliet Illinois
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center - North Kansas City Missouri
United States University of Kansas Cancer Center-West Kansas City Kansas
United States ECU Health Oncology Kenansville Kenansville North Carolina
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kaiser Permanente - Kensington Medical Center Kensington Maryland
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Ballad Health Cancer Care - Kingsport Kingsport Tennessee
United States ECU Health Oncology Kinston Kinston North Carolina
United States Thompson Cancer Survival Center Knoxville Tennessee
United States Thompson Cancer Survival Center - West Knoxville Tennessee
United States Mayo Clinic Health System-Franciscan Healthcare La Crosse Wisconsin
United States Good Samaritan Medical Center Lafayette Colorado
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Fairfield Medical Center Lancaster Ohio
United States Lancaster General Ann B Barshinger Cancer Institute Lancaster Pennsylvania
United States Lancaster General Hospital Lancaster Pennsylvania
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States Mid-Michigan Physicians-Lansing Lansing Michigan
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States McLaren Cancer Institute-Lapeer Region Lapeer Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States Kaiser Permanente - Largo Medical Center Largo Maryland
United States Memorial Medical Center - Las Cruces Las Cruces New Mexico
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Thompson Oncology Group-Lenoir City Lenoir City Tennessee
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Baptist Health Lexington Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States AMG Libertyville - Oncology Libertyville Illinois
United States Condell Memorial Hospital Libertyville Illinois
United States Cancer Partners of Nebraska Lincoln Nebraska
United States Cancer Partners of Nebraska - Pine Lake Lincoln Nebraska
United States Atrium Health Lincoln/LCI-Lincolnton Lincolnton North Carolina
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Loma Linda University Medical Center Loma Linda California
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States Baptist Health Louisville Louisville Kentucky
United States Medical Center of the Rockies Loveland Colorado
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States SSM Health Dean Medical Group - South Madison Campus Madison Wisconsin
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Thompson Oncology Group-Maryville Maryville Tennessee
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Kaiser Permanente Tysons Corner Medical Center McLean Virginia
United States Redeemer Health Meadowbrook Pennsylvania
United States Cone Heath Cancer Center at Mebane Mebane North Carolina
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Aspirus Medford Hospital Medford Wisconsin
United States Riddle Memorial Hospital Media Pennsylvania
United States Summa Health Medina Medical Center Medina Ohio
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States UH Seidman Cancer Center at Lake Health Mentor Campus Mentor Ohio
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States UH Seidman Cancer Center at Southwest General Hospital Middleburg Heights Ohio
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States NYU Langone Hospital - Long Island Mineola New York
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Forbes Hospital Monroeville Pennsylvania
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States West Virginia University Healthcare Morgantown West Virginia
United States McLaren Cancer Institute-Macomb Mount Clemens Michigan
United States McLaren Cancer Institute-Central Michigan Mount Pleasant Michigan
United States Knox Community Hospital Mount Vernon Ohio
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States The Community Hospital Munster Indiana
United States Women's Diagnostic Center - Munster Munster Indiana
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Edward Hospital/Cancer Center Naperville Illinois
United States ThedaCare Regional Medical Center - Neenah Neenah Wisconsin
United States Yale University New Haven Connecticut
United States Memorial Sloan Kettering Cancer Center New York New York
United States Mount Sinai Hospital New York New York
United States Mount Sinai Union Square New York New York
United States Mount Sinai West New York New York
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Piedmont Newnan Hospital Newnan Georgia
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Southwest VA Regional Cancer Center Norton Virginia
United States Norwalk Hospital Norwalk Connecticut
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Thompson Oncology Group-Oak Ridge Oak Ridge Tennessee
United States Kaiser Permanente-Oakland Oakland California
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States Integris Cancer Institute of Oklahoma Oklahoma City Oklahoma
United States Integris Southwest Medical Center Oklahoma City Oklahoma
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Kaiser Permanente-Ontario Ontario California
United States Saint Alphonsus Cancer Care Center-Ontario Ontario Oregon
United States Saint Joseph Hospital - Orange Orange California
United States Smilow Cancer Hospital-Orange Care Center Orange Connecticut
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States AdventHealth Orlando Orlando Florida
United States Orlando Health Cancer Institute Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Desert Regional Medical Center Palm Springs California
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States The Valley Hospital - Luckow Pavilion Paramus New Jersey
United States Advocate Lutheran General Hospital Park Ridge Illinois
United States Camden Clark Medical Center Parkersburg West Virginia
United States University Hospitals Parma Medical Center Parma Ohio
United States Illinois CancerCare-Pekin Pekin Illinois
United States Sacred Heart Hospital Pensacola Florida
United States Illinois CancerCare-Peoria Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Eastern Regional Medical Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Banner-University Medical Center Phoenix Phoenix Arizona
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States UPMC-Magee Womens Hospital Pittsburgh Pennsylvania
United States UPMC-Passavant Hospital Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Edward Hospital/Cancer Center?Plainfield Plainfield Illinois
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States McLaren-Port Huron Port Huron Michigan
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States University Hospitals Portage Medical Center Ravenna Ohio
United States Beebe Health Campus Rehoboth Beach Delaware
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States ECU Health Oncology Richlands Richlands North Carolina
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Kaiser Permanente-Richmond Richmond California
United States VCU Massey Cancer Center at Stony Point Richmond Virginia
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Neurosurgeons of New Jersey-Ridgewood Ridgewood New Jersey
United States Valley Health System Ridgewood Campus Ridgewood New Jersey
United States Presbyterian Rust Medical Center/Jorgensen Cancer Center Rio Rancho New Mexico
United States Kaiser Permanente-Riverside Riverside California
United States Mayo Clinic in Rochester Rochester Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States Levine Cancer Institute-Rock Hill Rock Hill South Carolina
United States UW Health Carbone Cancer Center Rockford Rockford Illinois
United States Penobscot Bay Medical Center Rockport Maine
United States Nash UNC HealthCare Rocky Mount North Carolina
United States Kaiser Permanente-Roseville Roseville California
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Kaiser Permanente Downtown Commons Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Kaiser Permanente-San Diego Zion San Diego California
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kaiser San Rafael-Gallinas San Rafael California
United States Kootenai Clinic Cancer Services - Sandpoint Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States North Coast Cancer Care Sandusky Ohio
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Community Medical Center Scranton Pennsylvania
United States Swedish Medical Center-First Hill Seattle Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Suburban Hematology Oncology Associates - Snellville Snellville Georgia
United States Memorial Hospital of South Bend South Bend Indiana
United States VCU Community Memorial Health Center South Hill Virginia
United States City of Hope South Pasadena South Pasadena California
United States Maine Medical Partners - South Portland South Portland Maine
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States Spartanburg Medical Center Spartanburg South Carolina
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Piedmont Henry Hospital Stockbridge Georgia
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Banner Boswell Medical Center Sun City Arizona
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States ProMedica Flower Hospital Sylvania Ohio
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States State University of New York Upstate Medical University Syracuse New York
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Holy Name Hospital Teaneck New Jersey
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States City of Hope South Bay Torrance California
United States Smilow Cancer Hospital-Torrington Care Center Torrington Connecticut
United States UM Saint Joseph Medical Center Towson Maryland
United States Munson Medical Center Traverse City Michigan
United States William Beaumont Hospital - Troy Troy Michigan
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Cancer Treatment Centers of America Tulsa Oklahoma
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Memorial Sloan Kettering Nassau Uniondale New York
United States City of Hope Upland Upland California
United States Crozer-Chester Medical Center Upland Pennsylvania
United States Carle Cancer Center Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States Kaiser Permanente-Vallejo Vallejo California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States Northwest Cancer Center - Valparaiso Valparaiso Indiana
United States Essentia Health Virginia Clinic Virginia Minnesota
United States MD Anderson Cancer Center at Cooper-Voorhees Voorhees New Jersey
United States Ridgeview Medical Center Waconia Minnesota
United States University Hospitals Sharon Health Center Wadsworth Ohio
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States South Pointe Hospital Warrensville Heights Ohio
United States Illinois CancerCare - Washington Washington Illinois
United States Kaiser Permanente-Capitol Hill Medical Center Washington District of Columbia
United States Marion L Shepard Cancer Center - ECU Health Beaufort Hospital Washington North Carolina
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
United States Smilow Cancer Hospital Care Center - Waterford Waterford Connecticut
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Valley Medical Group - Wayne Multispecialty Practice Wayne New Jersey
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Lexington Medical Center West Columbia South Carolina
United States Good Samaritan University Hospital West Islip New York
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States UH Seidman Cancer Center at Saint John Medical Center Westlake Ohio
United States UHHS-Westlake Medical Center Westlake Ohio
United States Cleveland Clinic-Weston Weston Florida
United States Marshfield Medical Center - Weston Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States Valley Health System-Hematology/Oncology Westwood New Jersey
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States UPMC Susquehanna Williamsport Pennsylvania
United States Asplundh Cancer Pavilion Willow Grove Pennsylvania
United States Shenandoah Oncology PC Winchester Virginia
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States UMass Memorial Medical Center - University Campus Worcester Massachusetts
United States Lankenau Medical Center Wynnewood Pennsylvania
United States University of Michigan Health - West Wyoming Michigan
United States UPMC Memorial York Pennsylvania
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio
United States Midwestern Regional Medical Center Zion Illinois

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival Will be determined using the current Response Evaluation Criteria in Solid Tumors 1.1 criteria. Analysis will be based on the intent to treat population. The stratified log-rank test will be used to compare the progression free survival between the two treatment arms with the following stratification factors: prior neoadjuvant or adjuvant therapy with trastuzumab (no; yes), estrogen receptor status (positive; negative), disease sites (any visceral without brain metastasis; non-visceral only without brain metastasis; brain metastasis), and choice of taxane (paclitaxel; docetaxel). The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio. The time from randomization to the first documented progressive disease every 6 months, assessed up to 8 years
Secondary Overall survival Analysis will be based on the intent to treat population. The stratification factors are the same as what are used in the stratified log-rank test for the primary analysis on progression free survival. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio. The time from randomization to death from any cause every 6 months, assessed up to 8 years
Secondary Overall objective response Defined as complete response or partial response. Will be determined using Response Evaluation Criteria in Solid Tumors 1.1 criteria. The stratified Cochran-Mantel-Haenszel test will be used to compare the object response between the treatment arms. Every 6 months up to 8 years
Secondary Frequency of adverse events, including late immune-related toxicities Will be categorized using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. Comparisons of the adverse events between the two treatment arms will be done by the Fisher's exact test. Every 6 months up to 8 years
See also
  Status Clinical Trial Phase
Recruiting NCT02778685 - Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer Phase 2
Completed NCT03106415 - Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer Phase 1/Phase 2
Active, not recruiting NCT02595905 - Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases Phase 2
Terminated NCT02149173 - F-18 FES PET/CT in Measuring Hormone Expression in Patients With Primary, Recurrent, or Metastatic Breast Cancer Undergoing Endocrine-Targeted Therapy N/A
Completed NCT00390455 - Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive Phase 3
Completed NCT00699491 - Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer Phase 1/Phase 2
Terminated NCT01957514 - Collecting, Analyzing, and Storing Samples From Patients With Metastatic, Triple Negative Breast Cancer Receiving Anti-cancer Therapy
Completed NCT03535701 - Ketogenic Diet and Chemotherapy in Affecting Recurrence in Patients With Stage IV Breast Cancer N/A
Completed NCT00785291 - Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer Phase 3
Completed NCT01251874 - Veliparib and Carboplatin in Treating Patients With HER2-Negative Metastatic Breast Cancer Phase 1
Active, not recruiting NCT03281902 - Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
Active, not recruiting NCT02208375 - mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian Phase 1/Phase 2
Recruiting NCT03418961 - S1501 Carvedilol in Preventing Cardiac Toxicity in Patients With Metastatic HER-2-Positive Breast Cancer Phase 3
Active, not recruiting NCT02398773 - FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy Phase 2
Active, not recruiting NCT02311933 - Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer Phase 2
Completed NCT01142401 - Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer Phase 2
Active, not recruiting NCT01351909 - Cyclophosphamide and Veliparib in Treating Patients With Locally Advanced or Metastatic Breast Cancer Phase 1
Active, not recruiting NCT00601900 - Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer Phase 3
Recruiting NCT03428802 - Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability Phase 2
Suspended NCT03432741 - Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer Phase 1