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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00601900
Other study ID # NCI-2009-00477
Secondary ID NCI-2009-00477CA
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 15, 2008
Est. completion date July 10, 2024

Study information

Verified date January 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 tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.


Description:

PRIMARY OBJECTIVES: I. To compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. SECONDARY OBJECTIVES: I. To compare the proportion of patients receiving letrozole alone, who remain progression-free at 6 and 12 months, to those receiving letrozole plus bevacizumab. II. To compare the incidence of objective response (complete response [CR] + partial response [PR]) in patients receiving letrozole with and without bevacizumab, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, excluding patients with non-measurable disease. III. To compare the incidence of clinical benefit (CR + PR + stable disease >= 6 months) in patients receiving letrozole with and without bevacizumab. IV. To compare the duration of objective response in patients receiving letrozole with and without bevacizumab. V. To compare the time to treatment failure in patients receiving letrozole with and without bevacizumab. VI. To compare the overall survival of patients receiving letrozole with and without bevacizumab, including the probability of survival until 36 months. VII. To compare toxicity levels between the bevacizumab arm and the arm without bevacizumab in both the letrozole-treated patients and in the tamoxifen-treated patients. VIII. To compare progression-free survival and overall survival of all patients receiving endocrine therapy with and without bevacizumab (by combining both letrozole and tamoxifen* patient subgroups). CORRELATIVE OBJECTIVES: I. To compare baseline and changes in serial levels of circulating endothelial cells and circulating tumor cells in patients treated with endocrine therapy alone or endocrine therapy plus bevacizumab, and to explore the relationship of these markers with progression free survival. II. To conduct proteomic analysis of longitudinal samples from patients with advanced-stage disease undergoing hormonal therapy to define new serum-based biomarkers related to disease activity. III. To identify biologic correlates that will predict progression-free survival (PFS) and response to therapy. IV. To conduct pharmacogenomic assessment of candidate variants in the VEGF, CYP2D6, and CYP19 genes and evaluate their association with PFS and other study outcomes. V. To identify single nucleotide polymorphisms (SNPs) associated with progression free survival in the genome-wide approach (GWAS). VI. To identify factors other than chronological age that predict the risk of grade 3, 4 or 5 toxicity with bevacizumab and endocrine therapy by means of functional age assessment measures. VII. To perform an exploratory analysis of the ability of the other factors included in the functional age assessment (either individual or in combination), to predict the risk of grade 3, 4 or 5 toxicity. VIII. To evaluate longitudinal changes in the parameters of the factors described in objective VI while on therapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. NOTE: The placebo-controlled portion of the study was canceled on 5-15-10. ARM I: Patients receive endocrine therapy* (tamoxifen citrate or letrozole) orally (PO) once daily (QD) on days 1-21 and bevacizumab intravenously (IV) over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive endocrine therapy* (tamoxifen citrate or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 6 months for the first 2 years and then annually for up to 3 years. * NOTE: As of 5/15/2011, patients only receive letrozole.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 394
Est. completion date July 10, 2024
Est. primary completion date June 30, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting - Stage IV disease or stage IIIB disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy - Patients may not have a "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse - Tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in >= 1% of cells will be considered positive - Postmenopausal women are eligible for this trial; before study registration, menopausal status must be defined according to the criteria below: - Age >= 55 years and one year or more of amenorrhea - Age < 55 years and one year or more of amenorrhea, with an estradiol assay < 20 pg/ml - For women age < 55 with prior hysterectomy but intact ovaries, with an estradiol assay < 20 pg/ml - Surgical menopause with bilateral oophorectomy (at least 28 days must elapse from surgery to time of study registration) - Ovarian suppression on a luteinizing hormone-releasing hormone (LH-RH) agonist - Premenopausal women who do not meet the postmenopausal criteria above are also eligible, but are required to undergo ovarian suppression; this can be initiated any time prior to or on day 1 of protocol therapy, regardless of chosen endocrine therapy, and will continue for the duration of protocol therapy - Patients must have measurable or non-measurable disease by RECIST criteria, with radiologic scans within 28 days of study registration - Measurable disease: lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan - Non-measurable disease: all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly non-measurable lesions - Lesions that are considered non-measurable include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Prior endocrine therapy is not required - Prior endocrine therapy in the metastatic setting is not permitted (unless tamoxifen or an aromatase inhibitor was initiated within 4 weeks prior to registration to facilitate enrollment of patients who recently started first-line endocrine therapy for metastatic breast cancer); if prior letrozole therapy was initiated within the past 4 weeks, the patients should remain on letrozole as the study therapy; patients who began therapy with tamoxifen, anastrozole or exemestane must switch to letrozole to be eligible to participate in this study - Prior endocrine therapy in the adjuvant setting is permitted; there is no time restriction for how long the patient must be on the adjuvant endocrine therapy, nor is there a time restriction for how long the patient needs to be off prior adjuvant endocrine therapy before beginning protocol therapy on 40503 - Prior treatment with ovarian suppression is allowed in either the adjuvant or metastatic setting; if medical ovarian suppression is being administered it can be initiated any time prior to or at the start of protocol therapy, and continued throughout the duration of the trial; surgical castration with bilateral oophorectomy must be performed at least 28 days prior to study registration (due to concerns of poor wound healing on bevacizumab) - Patients may not have received any prior anti-VEGF or VEGFR tyrosine kinase inhibitor therapy - Prior radiotherapy must have been completed and all toxicities resolved at least two weeks prior to registration - Chemotherapy in the adjuvant or neoadjuvant setting is permitted; at least twelve months prior to registration must have elapsed since the completion of adjuvant or neoadjuvant chemotherapy and all toxicities must have resolved; taxane-related neurotoxicity must have resolved to sensory grade < 2 and no motor neuropathy of any grade is allowed - Patients may have received one prior chemotherapy regimen for metastatic disease; the final dose of prior chemotherapy must have been administered at least 3 weeks prior to study registration - Treatment with bisphosphonates is allowed and recommended as per American Society of Clinical Oncology (ASCO) guidelines - Patients must not have had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study registration, and must have fully recovered from any such procedure - Patients must not have anticipation of need for major surgical procedure during the course of the study - Patients must not have had a core biopsy or other minor surgical procedure, within 7 days prior to study registration; placement of a vascular access device is allowed within 7 days of registration - Patients must not have a history of abdominal fistula, or intra-abdominal abscess within 6 months prior to study registration - Patients with a history of gastrointestinal (GI) perforation within 12 months prior to registration are not eligible - Patients with a history of significant bleeding episodes (e.g., hemoptysis, upper or lower GI bleeding) within 6 months prior to registration are not eligible - Patients must not have clinically significant cardiovascular disease that includes the following: - Uncontrolled hypertension defined as systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications or any prior history of hypertensive crisis or hypertensive encephalopathy - History of myocardial infarction or unstable angina within past 6 months - New York Heart Association (NYHA) grade 2 or greater congestive heart failure - Symptomatic peripheral vascular disease - Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or arterial thrombotic events - Full dose anticoagulation therapy is allowed for the treatment of prior conditions such as venous thrombosis or atrial fibrillation, but not for the treatment of prior arterial thrombotic events; patients on full dose anticoagulants must be on a stable dose of warfarin and have an in-range international normalized ratio (INR) (usually between 2 and 3) or be on a stable dose of low-molecular weight (LMW) heparin; patients receiving antiplatelet agents are eligible, as are patients on daily prophylactic aspirin or anticoagulation for atrial fibrillation - Patients may not have a history of stroke or transient ischemic attack within 6 months prior to study registration - Patients with a history of seizures must be well controlled with standard medication - Patients must not have known central nervous system (CNS) metastases or leptomeningeal disease (screening with brain imaging is not required for asymptomatic patients) - In aromatase inhibitor (AI)-treated patients: no known allergies to imidazole drugs, (e.g. clotrimazole, ketoconazole, miconazole, econazole, sulconazole, tioconazole, or terconazole) or compounds structurally similar to bevacizumab - In tamoxifen treated patients: no known allergies to selective estrogen receptor modulators (e.g. tamoxifen, raloxifene or toremifene) or compounds structurally similar to bevacizumab; for patients enrolled after Update #5, endocrine therapy will consist of letrozole only and this criterion will no longer apply - Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status =< 1 - No serious, non-healing wound, ulcer, or bone fracture - Life expectancy of >= 12 weeks - All patients who are premenopausal (if not already receiving ovarian suppression therapy/surgical oophorectomy) must have a negative beta-human chorionic gonadotropin (beta-Hcg) prior to starting on study treatment; patients may not be pregnant or nursing at any time during the study; ovarian suppression is required in women of childbearing potential by the start of protocol therapy, and will continue for the duration of protocol therapy - Granulocytes >= 1,000/ul - Platelet count >= 100,000/ul - Creatinine =< 2.0 mg/dL - Bilirubin =< 1.5 times upper limit of normal (ULN) unless due to Gilbert's syndrome - Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 times ULN - International normalized ratio (INR) =< 1.6, unless on full dose warfarin - Beta-Hcg negative in premenopausal women - Urine protein =< 1+ or urine to plasma creatinine (UPC) < 1 - Patients discovered to have >= 2+ proteinuria at baseline must undergo a 24-hour urine collection that must demonstrate < 1 g of protein/24 hr, or UPC ratio < 1 to allow participation in the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Bevacizumab
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Drug:
Letrozole
Given PO
Other:
Questionnaire Administration
Ancillary studies
Drug:
Tamoxifen Citrate
Given PO

Locations

Country Name City State
Puerto Rico San Juan City Hospital San Juan
United States Pali Momi Medical Center 'Aiea Hawaii
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Jefferson Abington Hospital Abington Pennsylvania
United States Medini, Eitan MD (UIA Investigator) Alexandria Minnesota
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States McFarland Clinic - Ames Ames Iowa
United States AnMed Health Cancer Center Anderson South Carolina
United States AnMed Health Hospital Anderson South Carolina
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States East Bay Medical Oncology Hematology Medical Associates-Antioch Antioch California
United States Randolph Hospital Asheboro North Carolina
United States Our Lady Bellefonte Hospital Ashland Kentucky
United States University Cancer and Blood Center LLC Athens Georgia
United States Atlanta Regional CCOP Atlanta Georgia
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Piedmont Hospital Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States WellStar Cobb Hospital Austell Georgia
United States Greater Baltimore Medical Center Baltimore Maryland
United States Sinai Hospital of Baltimore Baltimore Maryland
United States University of Maryland/Greenebaum Cancer Center Baltimore Maryland
United States Veterans Administration Medical Center-Baltimore Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Hematology/Oncology Clinic PLLC Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States McLaren Cancer Institute-Bay City Bay City Michigan
United States Franciscan Saint Francis Health-Beech Grove Beech Grove Indiana
United States Mary Rutan Hospital Bellefontaine Ohio
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Constantinou, Costas L MD (UIA Investigator) Bettendorf Iowa
United States University of Iowa Healthcare Cancer Services Quad Cities Bettendorf Iowa
United States Spectrum Health Big Rapids Hospital Big Rapids Michigan
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States OSF Saint Joseph Medical Center Bloomington Illinois
United States Boca Raton Regional Hospital Boca Raton Florida
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Boulder Community Hospital Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Wakefield Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Mills-Peninsula Medical Center Burlingame California
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Cooper Hospital University Medical Center Camden New Jersey
United States Aultman Health Foundation Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Southeast Missouri Hospital Cape Girardeau Missouri
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Rocky Mountain Oncology Casper Wyoming
United States East Bay Radiation Oncology Center Castro Valley California
United States Eden Hospital Medical Center Castro Valley California
United States Valley Medical Oncology Consultants-Castro Valley Castro Valley California
United States Providence Regional Cancer System-Centralia Centralia Washington
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Sentara Martha Jefferson Hospital Charlottesville Virginia
United States Erlanger Medical Center Chattanooga Tennessee
United States Advocate Illinois Masonic Medical Center Chicago Illinois
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Mercy Hospital and Medical Center Chicago Illinois
United States Mount Sinai Hospital Medical Center Chicago Illinois
United States Presence Resurrection Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adventist Health Cancer Care Center Chico Chico California
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States MetroHealth Medical Center Cleveland Ohio
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Community Cancer Institute Clovis California
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Columbus NCI Community Oncology Research Program Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States John B Amos Cancer Center Columbus Georgia
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 New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Ochsner Health Center-Covington Covington Louisiana
United States Hematology and Oncology Associates of Rhode Island Inc Cranston Rhode Island
United States Danville Regional Medical Center Danville Virginia
United States Dayton Veterans Affairs Medical Center Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Beaumont Hospital - Dearborn Dearborn Michigan
United States Decatur Memorial Hospital Decatur Illinois
United States Dekalb Medical Center Decatur Georgia
United States Heartland Cancer Research NCORP Decatur Illinois
United States Grady Memorial Hospital Delaware Ohio
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Western States Cancer Research NCORP Denver Colorado
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Mercy Capitol 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 Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Advocate Good Samaritan Hospital Downers Grove Illinois
United States Doylestown Hospital Doylestown Pennsylvania
United States Dublin Hematology Oncology Care PC Dublin Georgia
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Michigan State University Clinical Center East Lansing Michigan
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Ascension Alexian Brothers - Elk Grove Village Elk Grove Village Illinois
United States Elkhart Clinic Elkhart Indiana
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology PC-Elkhart Elkhart Indiana
United States Christiana Care - Union Hospital Elkton Maryland
United States Elmhurst Hospital Center Elmhurst New York
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Arnot Ogden Medical Center/Falck Cancer Center Elmira New York
United States Bay Area Breast Surgeons Inc Emeryville California
United States Swedish Medical Center Englewood Colorado
United States OSF Saint Francis Hospital and Medical Group Escanaba Michigan
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Kaiser Permanente - Fair Oaks Medical Center Fairfax Virginia
United States Piedmont Fayette Hospital Fayetteville Georgia
United States Saint Francis Hospital Federal Way Washington
United States Etzell, Paul S MD (UIA Investigator) Fergus Falls Minnesota
United States Swenson, Wade II, MD (UIA Investigator) Fergus Falls Minnesota
United States Blanchard Valley Hospital Findlay Ohio
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States McLaren Cancer Institute-Flint Flint Michigan
United States McLeod Regional Medical Center Florence South Carolina
United States Poudre Valley Hospital Fort Collins Colorado
United States Eisenhower Army Medical Center Fort Gordon Georgia
United States Holy Cross Hospital Fort Lauderdale Florida
United States Sparks Regional Medical Center Fort Smith Arkansas
United States Fort Wayne Medical Oncology and Hematology Inc-Parkview Fort Wayne Indiana
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Aurora Cancer Care-Franklin Franklin Wisconsin
United States Frederick Memorial Hospital Frederick Maryland
United States CentraState Medical Center Freehold New Jersey
United States Freeport Memorial Hospital/Leonard C Ferguson Cancer Center Freeport Illinois
United States Valley Medical Oncology Consultants-Fremont Fremont California
United States Florida Cancer Specialists-Gainesville Cancer Center Gainesville Florida
United States Northeast Georgia Medical Center-Gainesville Gainesville Georgia
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States Aurora Cancer Care-Glendale Glendale Wisconsin
United States Adirondack Cancer Center Glens Falls New York
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Cancer Research Consortium of West Michigan NCORP Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner North Colorado Medical Center Greeley Colorado
United States Aurora BayCare Medical Center Green Bay Wisconsin
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's Hospital 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 Marin General Hospital Greenbrae California
United States Cone Health Cancer Center Greensboro North Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Hackensack University Medical Center Hackensack New Jersey
United States Meritus Medical Center Hagerstown Maryland
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 Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Northern Montana Hospital Havre Montana
United States HaysMed Hays Kansas
United States Saint Peter's Community Hospital Helena Montana
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children 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 The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States Hutchinson Regional Medical Center Hutchinson Kansas
United States Cape Cod Hospital Hyannis Massachusetts
United States Ascension Saint Vincent Indianapolis Hospital Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Queens Hospital Center Jamaica New York
United States Mercyhealth Hospital and Cancer Center - Janesville Janesville Wisconsin
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Duly Health and Care Joliet Joliet Illinois
United States Freeman Health System Joplin Missouri
United States Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Glacier Oncology PLLC Kalispell Montana
United States Kalispell Medical Oncology Kalispell Montana
United States Kalispell Regional Medical Center Kalispell Montana
United States Presence Saint Mary's Hospital Kankakee Illinois
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene New Hampshire
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States ECU Health Oncology Kinston Kinston North Carolina
United States Community Howard Regional Health Kokomo Indiana
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States AMITA Health Adventist Medical Center La Grange Illinois
United States IU Health La Porte Hospital La Porte Indiana
United States LRGHealthcare-Lakes Region General Hospital Laconia New Hampshire
United States IU Health Arnett Cancer Care Lafayette Indiana
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States Karmanos Cancer Institute at McLaren Greater Lansing Lansing Michigan
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States Kaiser Permanente - Largo Medical Center Largo Maryland
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States Saint Rita's Medical Center Lima Ohio
United States Nebraska Cancer Research Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Sky Ridge Medical Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Los Angeles General Medical Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Doctors Carrol, Sheth, Raghavan Louisville Kentucky
United States Banner McKee Medical Center Loveland Colorado
United States Lowell General Hospital Lowell Massachusetts
United States Kaiser Permanente Lutherville - Timonium Medical Center Lutherville Maryland
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Atrium Health Navicent Macon Georgia
United States SSM Health Dean Medical Group - South Madison Campus Madison Wisconsin
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States Mayo Clinic Health Systems-Mankato Mankato Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Wellstar Kennestone Hospital Marietta Georgia
United States Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States UP Health System Marquette Marquette Michigan
United States Marshfield Medical Center Marshfield Wisconsin
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Contra Costa Regional Medical Center Martinez California
United States Fremont - Rideout Cancer Center Marysville California
United States Holy Family Hospital Methuen Massachusetts
United States Mount Sinai Medical Center Miami Beach Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Middlesex Hospital Middletown Connecticut
United States MyMichigan Medical Center Midland Midland Michigan
United States Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford Massachusetts
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States Michiana Hematology Oncology PC-Mishawaka Mishawaka Indiana
United States Saint Joseph Regional Medical Center-Mishawaka Mishawaka Indiana
United States Community Medical Center Missoula Montana
United States Guardian Oncology and Center for Wellness Missoula Montana
United States Montana Cancer Specialists Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Providence Hospital Mobile Alabama
United States Memorial Medical Center Modesto California
United States Garneau, Stewart C MD (UIA Investigator) Moline Illinois
United States Porubcin, Michael MD (UIA Investigator) Moline Illinois
United States Sharis, Christine M MD (UIA Investigator) Moline Illinois
United States Spector, David MD (UIA Investigator) Moline Illinois
United States Stoffel, Thomas J MD (UIA Investigator) Moline Illinois
United States Trinity Medical Center Moline Illinois
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Morristown Medical Center Morristown New Jersey
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States El Camino Hospital Mountain View California
United States Mercy Health Partners-Hackley Campus Muskegon Michigan
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Joseph Hospital Nashua New Hampshire
United States The Hospital of Central Connecticut New Britain Connecticut
United States Yale University New Haven Connecticut
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Baptist Medical Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Memorial Sloan Kettering Cancer Center 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 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States NYP/Weill Cornell Medical Center New York New York
United States Ralph Lauren Center for Cancer Care and Prevention New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Newark Beth Israel Medical Center Newark New Jersey
United States Providence Newberg Medical Center Newberg Oregon
United States Newton-Wellesley Hospital Newton Massachusetts
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Bromenn Regional Medical Center Normal Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States Great Plains Health Callahan Cancer Center North Platte Nebraska
United States Sutter Cancer Research Consortium Novato California
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute Oakland California
United States Hematology and Oncology Associates-Oakland Oakland California
United States Highland General Hospital Oakland California
United States Tom K Lee Inc 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 Olathe Cancer Center Olathe Kansas
United States Providence - Saint Peter Hospital Olympia Washington
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Missouri Valley Cancer Consortium Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Ottumwa Regional Health Center Ottumwa Iowa
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Singing River Hospital Pascagoula Mississippi
United States Memorial Hospital of Rhode Island Pawtucket Rhode Island
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States McLaren Cancer Institute-Northern Michigan Petoskey Michigan
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill Pleasant Hill California
United States John Muir Health Cancer Medical Group Pleasant Hill California
United States Valley Care Health System - Pleasanton Pleasanton California
United States Valley Medical Oncology Consultants Pleasanton California
United States Michiana Hematology Oncology PC-Plymouth Plymouth Indiana
United States Pomona Valley Hospital Medical Center Pomona California
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Adventist Medical Center Portland Oregon
United States Kaiser Permanente Northwest Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
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 Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Annie Penn Memorial Hospital Reidsville North Carolina
United States Renown Regional Medical Center Reno Nevada
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Reid Health Richmond Indiana
United States Southern Regional Medical Center Riverdale Georgia
United States Highland Hospital Rochester New York
United States Interlakes Foundation Inc-Rochester Rochester New York
United States University of Rochester Rochester New York
United States Kaiser Permanente - Shady Grove Medical Center Rockville Maryland
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Harbin Clinic Medical Oncology and Clinical Research Rome Georgia
United States Rutherford Hospital Rutherfordton North Carolina
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Cloud Hospital Saint Cloud Minnesota
United States Saint Helena Hospital Saint Helena California
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Comprehensive Cancer Care PC Saint Louis Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Saint Louis-Cape Girardeau CCOP Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Salina Regional Health Center Salina Kansas
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States UCSF Medical Center-Mount Zion San Francisco California
United States Zuckerberg San Francisco General Hospital San Francisco California
United States East Bay Medical Oncology Hematology Associates Inc San Leandro California
United States Doctors Medical Center- JC Robinson Regional Cancer Center San Pablo California
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Maine Center for Cancer Medicine-Scarborough Scarborough Maine
United States Mercy Hospital Scranton Pennsylvania
United States Scranton Hematology Oncology Scranton Pennsylvania
United States Grand View Hospital Sellersville Pennsylvania
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Welch Cancer Center Sheridan Wyoming
United States Holy Cross Hospital Silver Spring Maryland
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Avera McKennan Hospital and University Health Center Sioux Falls South Dakota
United States Medical X-Ray Center 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 Memorial Hospital of South Bend South Bend Indiana
United States Michiana Hematology Oncology PC-South Bend South Bend Indiana
United States Northern Indiana Cancer Research Consortium South Bend Indiana
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Spartanburg Medical Center Spartanburg South Carolina
United States Providence Holy Family Hospital Spokane Washington
United States Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington
United States Rockwood Clinic Spokane Washington
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Staten Island University Hospital Staten Island New York
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Aurora Medical Center in Summit Summit Wisconsin
United States Overlook Hospital Summit New Jersey
United States MultiCare Allenmore Hospital Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States North Suburban Medical Center Thornton Colorado
United States Cotton O'Neil Cancer Center / Stormont Vail Health Topeka Kansas
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Upper Valley Medical Center Troy Ohio
United States Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Natalie Warren Bryant Cancer Center at Saint Francis Tulsa Oklahoma
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States Faxton-Saint Luke's Healthcare Utica New York
United States Northbay Cancer Center Vacaville California
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Inspira Medical Center Vineland Vineland New Jersey
United States Maui Memorial Medical Center Wailuku Hawaii
United States Pacific Cancer Institute of Maui Wailuku Hawaii
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Kent Hospital Warwick Rhode Island
United States Sibley Memorial Hospital Washington District of Columbia
United States Aurora Cancer Care-Waukesha Waukesha Wisconsin
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Chester County Hospital West Chester Pennsylvania
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Michiana Hematology Oncology PC-Westville Westville Indiana
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Wheeling Hospital/Schiffler Cancer Center Wheeling West Virginia
United States UPMC Susquehanna Williamsport Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center Wilmington Ohio
United States Southeast Clinical Oncology Research Consortium NCORP Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Lankenau Medical Center Wynnewood Pennsylvania
United States University of Michigan Health - West Wyoming Michigan
United States Greene Memorial Hospital Xenia Ohio
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free Survival The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions. From randomization until disease progression or death whichever occurs first, assessed up to 5 years
Secondary 12 Month Progression Free Survival Rate The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study. At 12 months
Secondary 6 Month Progression-Free Survival Rate The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study. At 6 months
Secondary Objective Response Rate Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions. Assessed up to 5 years
Secondary Overall Survival (OS) OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method. Assessed up to 5 years
Secondary Duration of Tumor Response Defined by RECIST criteria. From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years
Secondary Probability of Surviving Until 36 Months At 36 months
Secondary Site of Progression Up to 5 years
Secondary Time-to-treatment Failure From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure Up to 5 years
Secondary Treatment Related Toxicity Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm. Up to 5 years
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