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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05929768
Other study ID # S2212
Secondary ID NCI-2023-02688S2
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 15, 2023
Est. completion date April 2033

Study information

Verified date October 2023
Source SWOG Cancer Research Network
Contact Alicia Aranda
Phone 210-614-8808
Email aaranda@swog.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.


Description:

PRIMARY OBJECTIVE: I. To assess whether participants with early stage triple negative breast cancer (TNBC) randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have non-inferior breast cancer event-free survival (BC-EFS) compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab. SECONDARY OBJECTIVES: I. To compare pathological complete response (pCR) and residual cancer burden (RCB) rates by randomized arm. II. To compare pCR and RCB rates between randomized arms by tumor infiltrating lymphocytes (TIL) status. III. To compare BC-EFS between randomized arms in the TIL-enriched and non-TIL enriched subgroups. IV. To compare distant relapse-free survival and overall survival by randomized arm. V. To compare invasive breast cancer-free survival after surgery between randomized arms in pCR and residual disease groups. VI. To compare the safety and tolerability by randomized arm among those that initiate therapy. TRANSLATIONAL MEDICINE OBJECTIVE: I. To evaluate concordance and accuracy of an automated stromal TIL (sTIL) algorithm versus (vs.) central pathologist assessed sTILs quantification. PATIENT REPORTED OUTCOME (PRO) OBJECTIVES: I. To compare patient-reported fatigue at 3 weeks after the last neoadjuvant systemic therapy (NAST) dose and, separately, at 18 months after randomization, using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue-7a in participants undergoing NAST with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy. (Quality of Life, Primary) II. To compare physical function experienced by participants undergoing neoadjuvant systemic chemotherapy (NAST) with taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy, within 3-5 weeks post last neoadjuvant systemic therapy dose using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) III. To compare physical function experienced by participants undergoing NAST taxane-platinum-anthracycline chemo-immunotherapy vs taxane-platinum chemo-immunotherapy at 18 months post registration using the PROMIS-29 Profile physical function subscale score. (Quality of Life, Secondary) IV. To compare other PROMIS-29 Profile subscale scores (sleep disturbance, depression, anxiety, social, pain interference, and pain sensitivity) and GP5 question response by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) V. To compare the GP-5 item scores by arm within 3-5 weeks post last neoadjuvant systemic therapy dose and at 18 months post registration. (Quality of Life, Exploratory) VI. To compare select patient-reported outcomes using the Common Terminology Criteria for Adverse Events (PRO-CTCAE) by arm. (Patient-Reported Symptoms of Treatment) BANKING OBJECTIVE: I. To bank physical specimens and digital slides for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive paclitaxel intravenously (IV), carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. ARM II: Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial. Patients are followed up every 6 months for the first 2 years and then annually until 5 years from registration.


Recruitment information / eligibility

Status Recruiting
Enrollment 2400
Est. completion date April 2033
Est. primary completion date March 31, 2033
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have histologically confirmed estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative breast cancer (TNBC) defined as ER < 5%, PR < 5%, and HER2 negative (per 2020 American Society of Clinical Oncology [ASCO] College of American Pathologists [CAP] guidelines) - NOTE: Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-4% by immunohistochemistry, are eligible if adjuvant endocrine therapy is not recommended/planned by the treating physician - Participants must have American Joint Committee on Cancer (AJCC) 8 anatomic tumor clinical stage either - T2-T4, N0, M0 or - T1-T3, N1-2, M0 - Note: All participants with clinically suspicious nodes must undergo core needle biopsy or fine needle biopsy per standard clinical practice to pathologically confirm nodal status - Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or magnetic resonance imaging (MRI) within 49 days prior to randomization - Note: Participants with bilateral invasive breast cancer are eligible if both breast cancers are ER-negative, PR-negative, and HER2-negative provided they meet the other eligibility criteria - Participants must not have T4/N+, any N3, or inflammatory breast cancer - Participants must not have metastatic disease (M1) - Participants must not have received prior systemic therapy or radiation therapy with curative intent for the current breast cancer - Participants must not have had previous definitive ipsilateral breast surgery for the current breast cancer - Participants must not have current or anticipated use of other investigational agents while participating in this study - Participants must not have history of allergic reactions attributed to compounds of similar chemical or biologic composition as study agents - Participants must not have severe hypersensitivity (>= grade 3) to pembrolizumab or any of its excipients - Participants must not have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) - Participants must not be currently participating in or have participated in a study of an investigational agent or used an investigational device within 28 days prior to randomization - Participants must be >= 18 years old - Participants must have Zubrod performance status of 0-2 - Participants with evidence of peripheral neuropathy must have it at =< grade 1, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to randomization - Participants must have a complete medical history and physical exam within 28 days prior to randomization - Hemoglobin >= 9.0 g/dL or >= 5.6 mol/L (within 28 days prior to randomization) - (Criteria must be met without erythropoietin dependency and without packed red blood cell transfusion within last 2 weeks) - Leukocytes >= 3 x 10^3/uL (within 28 days prior to randomization) - Absolute neutrophil count >= 1.5 x 10^3/uL (within 28 days prior to randomization) - Platelets >= 100 x 10^3/uL (within 28 days prior to randomization) - Total bilirubin =< 1.5 x institutional upper limit of normal (IULN), OR direct bilirubin =< IULN for participants with total bilirubin > 1.5 x IULN (unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional IULN) (within 28 days prior to randomization) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) - Participants must have a serum creatinine =< the IULN OR calculated creatinine clearance >= 50 mL/min/1.73m^2 using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration - Participants must have adequate cardiac function. Participants must have left ventricular ejection fraction >= 50% as assessed by either echocardiography (ECHO) or multigated acquisition scan (MUGA) assessed within 28 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better - Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization - Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated - Note: No testing for Hepatitis B is required unless mandated by local health authority - Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated - Note: No testing for hepatitis C is required unless mandated by local health authority - Participants with history of diabetes must not have uncontrolled diabetes in the opinion of the treating investigator - Participants must not have uncontrolled hypertension in the opinion of the treating investigator - Participants must not have had a major surgery within 14 days prior to randomization. Participants must have fully recovered from the effects of prior major surgery in the opinion of the treating investigator - Participants must not have severe or active infections within 14 days prior to Randomization, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia - Participants must not have a diagnosis of immunodeficiency and be receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization - Participants must not have active autoimmune disease that has required systemic treatment in 2 years prior to randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment - Participants must not have a history of (non-infectious) pneumonitis that required steroids, or has current (non-infectious) pneumonitis - Participants must not have received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist [registered trademark]) are live attenuated vaccines and are not allowed - Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen - Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen - Participants must have one (1) physical 4-5-micron single hematoxylin and eosin (H&E) slide from the archival pretreatment diagnostic biopsy available for submission - Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System - Participants who can complete questionnaires in English, Spanish, or French must be offered the opportunity to participate in the Patient-Reported Outcome study - NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines - For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations - As part of the registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo collection of blood samples
Drug:
Carboplatin
Given IV
Cyclophosphamide
Given IV
Docetaxel
Given IV
Doxorubicin
Given IV
Paclitaxel
Given IV
Biological:
Pembrolizumab
Given IV
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Procedure:
Surgical Procedure
Undergo surgery

Locations

Country Name City State
Puerto Rico Cancer Center-Metro Medical Center Bayamon Bayamon
Puerto Rico Doctors Cancer Center Manati
Puerto Rico Centro Comprensivo de Cancer de UPR San Juan
Puerto Rico PROncology San Juan
Puerto Rico San Juan City Hospital San Juan
Puerto Rico San Juan Community Oncology Group San Juan
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hickman Cancer Center Adrian Michigan
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States Community Hospital of Anaconda Anaconda Montana
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Sutter Auburn Faith Hospital Auburn California
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Rush - Copley Medical Center Aurora Illinois
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Flaget Memorial Hospital Bardstown Kentucky
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Alta Bates Summit Medical Center-Herrick Campus Berkeley California
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States Beverly Hospital Beverly Massachusetts
United States Tower Cancer Research Foundation Beverly Hills California
United States Billings Clinic Cancer Center Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
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 Central Care Cancer Center - Bolivar Bolivar Missouri
United States Bozeman Deaconess Hospital Bozeman Montana
United States Cox Cancer Center Branson Branson Missouri
United States Harrison Medical Center Bremerton Washington
United States Saint Joseph Mercy Brighton Brighton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Lahey Hospital and Medical Center Burlington Massachusetts
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Mercy Cancer Center ?? Carmichael Carmichael California
United States Mercy San Juan Medical Center Carmichael California
United States Caro Cancer Center Caro Michigan
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Eden Hospital Medical Center Castro Valley California
United States Mercy Hospital Cedar Rapids Iowa
United States Oncology Associates at Mercy Medical Center Cedar Rapids Iowa
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Saint Mary's Hospital Centralia Illinois
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States Cancer Center of Kansas - Chanute Chanute Kansas
United States Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Northwestern University Chicago Illinois
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Billings Clinic-Cody Cody Wyoming
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 Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States Saint Francis Cancer Center Colorado Springs Colorado
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Greater Regional Medical Center Creston Iowa
United States Carle at The Riverfront Danville Illinois
United States Sutter Davis Hospital Davis California
United States Dayton Blood and Cancer Center Dayton Ohio
United States Dayton Physician LLC-Miami Valley Hospital North 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 Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States National Jewish Health-Main Campus Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States Mercy Medical Center - 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 Illinois CancerCare-Dixon Dixon Illinois
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
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 Pocono Medical Center East Stroudsburg Pennsylvania
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
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 Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Mercy Cancer Center - Elk Grove Elk Grove California
United States Christiana Care - Union Hospital Elkton Maryland
United States Walter Knox Memorial Hospital Emmett Idaho
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Main Line Health Center-Exton Exton Pennsylvania
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Beaumont Hospital - Farmington Hills Farmington Hills Michigan
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
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 Hurley Medical Center Flint Michigan
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States Beebe South Coastal Health Campus Frankford Delaware
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Glens Falls Hospital Glens Falls New York
United States Addison Gilbert Hospital Gloucester Massachusetts
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States SCL Health Cancer Centers of Colorado - Lutheran Medical Center Golden Colorado
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Dayton Physicians LLC-Wayne Greenville Ohio
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 Wayne Hospital Greenville Ohio
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Legacy Mount Hood Medical Center Gresham Oregon
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 HaysMed University of Kansas Health System Hays Kansas
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Cancer Center of Kansas-Independence Independence Kansas
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States University of Mississippi Medical Center Jackson Mississippi
United States Capital Region Southwest Campus Jefferson City Missouri
United States NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro Arkansas
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Kalispell Regional Medical Center Kalispell Montana
United States Truman Medical Centers Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Cancer Center of Kansas-Kingman Kingman Kansas
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States The Watson Clinic Lakeland Florida
United States Saint Anthony Hospital Lakewood Colorado
United States Sparrow Hospital Lansing Michigan
United States Lawrence Memorial Hospital Lawrence Kansas
United States Beebe Medical Center Lewes Delaware
United States Saint Joseph Hospital Lexington Kentucky
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States CARTI Cancer Center Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Saint Joseph London London Kentucky
United States Longmont United Hospital Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Cancer Center of Kansas-Manhattan Manhattan Kansas
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Toledo Clinic Cancer Centers-Maumee Maumee Ohio
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Riddle Memorial Hospital Media Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bon Secours Westchester Emergency Center Midlothian Virginia
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Hospital Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Memorial Medical Center Modesto California
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Saint Joseph Mount Sterling Mount Sterling Kentucky
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Palo Alto Medical Foundation-Gynecologic Oncology Mountain View California
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Providence Queen of The Valley Napa California
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States Louisiana State University Health Science Center New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Providence Newberg Medical Center Newberg Oregon
United States Cancer Center of Kansas - Newton Newton Kansas
United States Bryn Mawr Health Center Newtown Square Pennsylvania
United States Sutter Cancer Research Consortium Novato California
United States Cancer Care Center of O'Fallon O'Fallon Illinois
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 Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Saint Alphonsus Medical Center-Ontario Ontario Oregon
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Northwestern Medicine Orland Park Orland Park Illinois
United States Lake Regional Hospital Osage Beach Missouri
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Desert Regional Medical Center Palm Springs California
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Midlands Community Hospital Papillion Nebraska
United States Parker Adventist Hospital Parker Colorado
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Lahey Medical Center-Peabody Peabody Massachusetts
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst North Carolina
United States 21st Century Oncology-Pontiac Pontiac Michigan
United States Hope Cancer Center Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Saint Joseph Mercy Oakland Pontiac Michigan
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 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Cancer Center of Kansas - Pratt Pratt Kansas
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Women and Infants Hospital Providence Rhode Island
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States Saint Charles Health System-Redmond Redmond Oregon
United States Beebe Health Campus Rehoboth Beach Delaware
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia
United States Bon Secours Richmond Community Hospital Richmond Virginia
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Reid Health Richmond Indiana
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States SwedishAmerican Regional Cancer Center/ACT Rockford Illinois
United States Mercy Cancer Center - Rocklin Rocklin California
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Cancer Care Associates PC Royal Oak Michigan
United States Comprehensive Medical Center PLLC Royal Oak Michigan
United States Hematology Oncology Consultants PC Royal Oak Michigan
United States Oakland Colon Rectal Associates Royal Oak Michigan
United States Oakland Medical Group Royal Oak Michigan
United States William Beaumont Hospital-Royal Oak Royal Oak Michigan
United States Mercy Cancer Center - 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 Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South 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 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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States California Pacific Medical Center-Pacific Campus San Francisco California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Mills Health Center San Mateo California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Providence Medical Foundation - Santa Rosa Santa Rosa California
United States Providence Santa Rosa Memorial Hospital Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Welch Cancer Center Sheridan Wyoming
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 Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
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 Premier Hematology Oncology Care Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri
United States Cedars-Sinai Cancer - Tarzana Tarzana California
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Lewis Hall Singletary Oncology Center Thomasville Georgia
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Torrance Memorial Physician Network - Cancer Care Torrance California
United States Dayton Physicians LLC - Troy Troy Ohio
United States Hematology Oncology Consultants PC-Troy Troy Michigan
United States Michigan Institute of Urology-Town Center Troy Michigan
United States Upper Valley Medical Center Troy Ohio
United States William Beaumont Hospital - Troy Troy Michigan
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Carle Cancer Center Urbana Illinois
United States Sutter Solano Medical Center/Cancer Center Vallejo California
United States South Nassau Cancer Center Valley Stream New York
United States Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Illinois CancerCare - Washington Washington Illinois
United States Mercy Hospital Washington Washington Missouri
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States Lexington Medical Center West Columbia South Carolina
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Marshfield Medical Center - Weston Weston Wisconsin
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Winchester Hospital Winchester Massachusetts
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Woodland Memorial Hospital Woodland California
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Fairview Lakes Medical Center Wyoming Minnesota
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan

Sponsors (2)

Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Breast cancer event-free survival (BC-EFS) Time from randomization to the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. BC-EFS will be compared between the treatment arms using Cox regression with adjustment for nodal status and sTIL enrichment. Up to 5 years
Secondary Pathologic complete response (pCR) pCR rates by assigned treatment arm will be compared using a difference of two proportions overall and by stromal tumor infiltrating lymphocytes (sTIL) group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group. From date of randomization to date of the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause, assessed up to 5 years
Secondary Residual cancer burden (RCB) RCB 0/I rates (i.e., RCB-0 and RCB-I combined) by assigned treatment arm will be compared using a difference of two proportions overall and by sTIL group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group. Up to 5 years
Secondary Distant relapse-free survival (DRFS) DRFS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. From date of randomization to date of invasive distant disease recurrence or death due to any cause, assessed up to 5 years
Secondary Overall survival (OS) OS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. From date of randomization to date of death due to any cause, assessed up to 5 years
Secondary Distant relapse-free interval (DRFI) DRFI will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. Deaths not due to breast cancer will be considered competing risks in this analysis. Cumulative incidence curves will describe the two arms over the follow-up period from randomization. From date of randomization to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
Secondary Relapse free survival (RFS) RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who had pCR. Nodal status and sTIL status will be included as covariates if there are sufficient numbers of events for the analysis. The expectation is that invasive breast cancer-free survival after pCR should not differ by treatment assignment. From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
Secondary RFS RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who did not have a pCR. Nodal status and sTIL status will be included as covariates. From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
Secondary Incidence of adverse events Rates of adverse events will be compared between treatment arms for those initiating the assigned therapy. Up to 5 years
Secondary Patient-Reported Fatigue Participant-reported fatigue will be compared between treatment arms using the Participant-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a at 3 weeks after the last neoadjuvant systemic therapy dose and at 18 months after randomization. The PROMIS Fatigue-7a is a validated 7-item questionnaire that assesses participant-reported fatigue in the past 7 days. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher T-scores indicate more fatigue. Up to 18 months
Secondary Patient-Reported Physical Function Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 3-5 weeks after the last neoadjuvant systemic therapy dose. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function. Up to 5 weeks after the last neoadjuvant systemic therapy dose
Secondary Patient-Reported Physical Function Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 18 months after randomization. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function. Up to 18 months
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