Breast Cancer Clinical Trial

Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

Summary

The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

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Full Description

NSABP B-59/GBG 96-GeparDouze is a prospective, randomized, double-blind, Phase III clinical trial. This is a collaborative study being conducted by NSABP Foundation, Inc. in partnership with the German Breast Group (GBG), and supported by funding by Genentech, a Member of the Roche Group, and F. Hoffmann-La Roche, Ltd.

In this clinical trial of neoadjuvant and adjuvant administration of atezolizumab/placebo in patients with high risk triple-negative breast cancer, the potential incremental efficacy and safety of neoadjuvant administration of atezolizumab/placebo with a sequential regimen of weekly paclitaxel with every-3-week carboplatin followed immediately by neoadjuvant administration of atezolizumab/placebo with AC/EC will be evaluated. Patients will then undergo surgery. Following recovery from surgery, patients will initiate approximately 6 months of adjuvant therapy with atezolizumab/placebo and receive the same investigational agent they received pre-operatively. Administration of radiation therapy will be based on local standards at the discretion of patients and investigators, but if administered, atezolizumab/placebo will be administered concurrently. Adjuvant atezolizumab/placebo may be delayed until after completion of radiation therapy per investigator discretion. Patients with residual invasive cancer at the time of surgery may receive capecitabine concurrently with atezolizumab/placebo in the adjuvant setting per investigator discretion and local guidelines. Patients with germline BRCA1 or BRCA2 mutations with residual invasive cancer at the time of surgery may receive olaparib in the adjuvant setting per investigator discretion and local guidelines. Patients receiving olaparib must discontinue atezolizumab/placebo.

The primary aims of the study are 1) to determine value of atezolizumab in improving pathologic complete response in the breast and post-therapy lymph nodes evaluated histologically (pCR breast and nodes [(ypT0/Tis ypN0)]), and 2) to determine the value of atezolizumab in improving event-free survival (EFS). Secondary aims include: pathologic complete response in the breast (ypT0/Tis); pathologic complete response in the breast and lymph nodes (ypT0 ypN0); positive nodal status conversion rate; overall survival; recurrence-free interval: distant disease-free survival; brain metastases free survival; and toxicity. The stratification factors for the study are: 1) clinical size of the primary tumor (1.1-3.0 cm; > 3.0 cm); 2) nodal status as determined by protocol-specified criteria (negative, positive); 3) AC/EC (every 2 weeks; every 3 weeks); and 4) Region (North America; Europe).

For patient eligibility, local testing on the diagnostic core must have determined the patient's tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. Material from either the diagnostic core biopsy or the research biopsy must be sent for central testing for confirmation of ER, PgR, and HER2 to confirm eligibility. If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both), material may be submitted for central testing to determine eligibility.

In order to proactively identify and further assess any cardiac toxicity that may occur with the combination of anthracyclines and atezolizumab, this study includes a cardiac safety lead-in for the first 60 patients who initiate AC/EC. The safety lead-in will consist of assessment of ECG and serum troponin-T obtained just prior to administration of the first dose of AC/EC, following completion of the administration of the 1st and 3rd cycle of AC/EC prior to initiation of the atezolizumab/placebo. An additional assessment of LVEF with echocardiogram or MUGA scan will also be obtained prior to the 3rd dose of AC/EC. In order to provide an early assessment of cardiac safety, results of the troponin-T assessments, ECGs, LVEF assessment, and cardiac safety data will be evaluated by the Data Safety Monitoring Board (DSMB) when the last of the initial 20 patients who initiate AC/EC undergo their scheduled post-surgery LVEF assessment. When the last of the first 60 patients to initiate AC/EC undergo their scheduled post-surgery LVEF assessment, results of the troponin assessments, ECGs, LVEF assessments, and cardiac safety data from all 60 patients will be evaluated by the DSMB.

Research core biopsies of breast primary at baseline and 1-4 days prior to the second dose of atezolizumab/placebo are a study requirement for all patients. One to three representative blocks of residual primary tumor containing the maximum amount of tumor and node with the largest focus of metastasis is required from the definitive breast surgery if gross residual disease is greater than or equal to 1.0 cm. If gross residual disease is less than 1.0 cm, tissue should be submitted, if possible. Blood specimens will be collected on all patients at baseline for exploratory biomarker analysis and to support future correlative studies.

Accrual to NSABP B-59/GBG 96-GeparDouze began in December 2017 and was completed in May 2021 with a total of 1550 patients randomized. Based on actual accrual and the decision to eliminate pCR as a co-primary endpoint, we recalculated the power to detect a hazard ratio of 0.70 attributed to the addition of atezolizumab, assuming a lost-to-follow-up rate of 0.00083 per month, using the actual accrual pattern for the power calculation. With 1550 patients accrued in 42 months, an additional 22 months follow up will allow us to obtain 252 events under the assumptions stated above, which will provide 80% power to detect a HR of 0.7 between the atezolizumab and the placebo arm at an overall 2-sided alpha level of 0.05.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The patient must have consented to participate and, prior to beginning specific study procedures, must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for study treatment and for submission of tumor samples from a research biospy as required by NSABP B-59/GBG 96-GeparDouze for baseline correlative science studies.
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.
Local testing on the diagnostic core must have determined the tumor to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP guidelines. (If local testing has determined a tumor to be HER2 equivocal or to have a borderline ER/PgR status (% IHC staining < 10% for both) and other eligibility criteria are met, material may be submitted for central testing to determine eligibility.)
Central testing for ER, PgR, and HER2 will be performed, and the tumor must be determined to be ER-negative, PgR-negative, and HER2-negative by current ASCO/CAP Guidelines Recommendations.
The tumor specimen used for central ER, PgR, and HER2 testing must also be used for central testing of PD-L1 status using the Ventana PD-L1 testing result including PD-L1 indeterminate Patients will be classifies as positive, negative, or indeterminate for stratification purposes.
Patients must be ≥ 18 years old.
Patient may be female or male.
The ECOG performance status must be 0-1.
The primary tumor can be clinical stage T2 or T3, if clinically node negative according to AJCC 7th Edition. If the regional lymph nodes are cN1 and cytologically or histologically positive or cN2-N3 with or without a biopsy, the primary breast tumor can be clinically T1c, T2, or T3.

Ipsilateral axillary lymph nodes must be evaluated by imaging (mammogram, ultrasound, and/or MRI) within 84 days prior to study entry. If suspicious or abnormal, FNA or core biopsy is recommended. Findings of these evaluations will be used to define the nodal status prior to study entry according to the following criteria:

Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node[s] on imaging is negative)
Nodal status - positive (FNA or core biopsy of the node[s] is cytologically or histologically suspicious or positive; Imaging is suspicious or abnormal but FNA or core biopsy was not performed.)
Patients with synchronous bilateral or multicentric HER2-negative breast cancer are eligible as long as the highest risk tumor is ER-negative and PgR-negative and meets stage eligibility criteria. All of the other invasive tumors must also be HER2-negative by ASCO/CAP Guidelines based on local testing. Central testing to confirm TNBC status is only required for the highest risk tumor.

Blood counts performed within 28 days prior to randomization must meet the following criteria:

ANC must be ≥ 1500/mm3;
platelet count must be ≥ 100,000/mm3; and
hemoglobin must be ≥10 g/dL.

The following criteria for evidence of adequate hepatic function performed within 28 days prior to randomization must be met:

total bilirubin must be ≤ ULN for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
alkaline phosphatase must be ≤ 2.5 x ULN for the lab; and
AST and ALT must be ≤ 1.5 x ULN for the lab.
Patients with AST or ALT or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, abdominal ultrasound, PET-CT, or PET scan) performed within 28 days prior to randomization does not demonstrate metastatic disease and the requirements in criterion (just above) are met.
Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN or with unexplained bone pain are eligible for inclusion in the study if bone imaging (bone scan, PET-CT scan, or PET scan) supported by additional studies when indicated (CT, x-ray, MRI) performed within 28 days prior to randomization does not demonstrate metastatic disease.
Patients with N2 or N3 nodal disease or T3 primary disease must undergo liver and bone imaging (as described in 4.1.13 and 4.1.14) within 28 days prior to randomization, irrespective of baseline lab results, and studies must not demonstrate metastatic disease. Chest imaging with chest x-ray PA and Lateral, CT of the chest, or PET-CT must also be performed.
Creatinine clearance ≥ 50 mL/min (see Section 7.2.1 for instructions regarding calculation of creatinine clearance) performed within 28 days prior to randomization.
PT/INR ≤ ULN within 28 days of randomization. Patients receiving therapeutic anti-coagulants are not eligible.
A serum TSH and AM (morning) cortisol performed within 28 days prior to randomization to obtain a baseline value. Patients with abnormal TSH or AM cortisol baseline levels should be further evaluated and managed per institutional standards. Asymptomatic patients who require initiation or adjustment of medication or are followed without initiating treatment based on endocrinologist's recommendations are eligible.
LVEF assessment must be performed within 42 days prior to randomization. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional preferences.) The LVEF must be ≥ 55% regardless of the cardiac imaging facility's lower limit of normal.

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo or 12 months after the last dose of chemotherapy.

A woman is considered to be of childbearing potential if she is not postmenopausal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of < 1% per year include: bilateral tubal ligation; male partner sterilization; hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices.
The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Excisional biopsy or lumpectomy performed prior to study entry.
FNA alone to diagnose the breast cancer.
Surgical axillary staging procedure prior to randomization. Exception: FNA or core biopsy of an axillary node is permitted for any patient. A pre-neoadjuvant therapy sentinel lymph node biopsy for patients with clinically negative axillary nodes is prohibited.
Definitive clinical or radiologic evidence of metastatic disease.
Previous history of contralateral invasive breast cancer. (Patients with synchronous and/or previous contralateral DCIS or LCIS are eligible.)
Previous history of ipsilateral invasive breast cancer or ipsilateral DCIS. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
Treatment including radiation therapy, chemotherapy, or targeted therapy, for the currently diagnosed breast cancer prior to randomization.
Previous therapy with anthracyclines or taxanes for any malignancy.

Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to:

Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; or symptomatic pericarditis.
History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular function within 6 months prior to randomization; history of documented CHF; or documented cardiomyopathy.
Uncontrolled hypertension defined as sustained systolic BP > 150 mmHg or diastolic BP > 90 mmHg. (Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.) Patients requiring ≥ 3 BP medications are not eligible.
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells.
Known allergy or hypersensitivity to the components of the atezolizumab formulation.
Known allergy or hypersensitivity to the components of the doxorubicin, epirubicin, cyclophosphamide, carboplatin, or paclitaxel formulations.
Known allergy or hypersensitivity to liposomal or pegylated G-CSF formulations.

Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:

Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.
Patients with controlled Type 1 diabetes mellitus on a stable dose of insulin regimen may be eligible for this study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are permitted provided all of following conditions are met: Rash must cover < 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
Patients known to be HIV positive.
Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV DNA viral load per local guidelines.
Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV RNA.
Patients with clinically active tuberculosis.
Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Prior allogeneic stem cell or solid organ transplantation.
Administration of a live, attenuated vaccine within 28 days prior to randomization or anticipation that such vaccine will be required during the study. Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 28 days prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization.
Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study.
Nervous system disorder (paresthesias, peripheral motor neuropathy, or peripheral sensory neuropathy) ≥ Grade 2, per the CTCAE v4.0.
Symptomatic peripheral ischemia.
Pregnancy or lactation at the time of randomization or intention to become pregnant during the study. (Note: Negative serum pregnancy test must be obtained within 14 days prior to randomization).
Use of any investigational agent within 28 days prior to randomization.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1550

Study ID:

NCT03281954

Recruitment Status:

Active, not recruiting

Sponsor:

NSABP Foundation Inc

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There are 197 Locations for this study

See Locations Near You

University of South Alabama Mitchell Cancer Institute
Mobile Alabama, 36604, United States
Katmai Oncology Group
Anchorage Alaska, 99508, United States
St. Bernard's Medical Center
Jonesboro Arkansas, 72401, United States
St. Bernard's Medical Center
Paragould Arkansas, 72450, United States
Kaiser Permanente-Anaheim
Anaheim California, 92806, United States
Kaiser Permanente-Baldwin Park
Baldwin Park California, 91706, United States
Kaiser Permanente-Bellflower
Bellflower California, 90706, United States
Arrowhead Regional Medical Center
Colton California, 92324, United States
City of Hope
Duarte California, 91010, United States
Kaiser Permanente-Fontana
Fontana California, 92335, United States
Kaiser Permanente-Harbor City
Harbor City California, 90710, United States
Kaiser Permanente-Irvine
Irvine California, 92618, United States
Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States
Kaiser Permanente-Sunset
Los Angeles California, 90027, United States
Kaiser Permanente-West Los Angeles
Los Angeles California, 90034, United States
Kaiser Permanente-Panorama City
Panorama City California, 91402, United States
Kaiser Permanente-Riverside
Riverside California, 92505, United States
Kaiser Permanente Medical Group
San Diego California, 92108, United States
Kaiser Permanente-Zion
San Diego California, 92120, United States
Kaiser Permanente - Otay
San Diego California, 92153, United States
Kaiser Permanente- San Marcos
San Marcos California, 92078, United States
City of Hope - South Pasadena
South Pasadena California, 91030, United States
Torrance Memorial Physician Network
Torrance California, 90505, United States
City of Hope - Upland
Upland California, 91786, United States
PIH Health
Whittier California, 90602, United States
Kaiser Permanente-Woodland Hills
Woodland Hills California, 91367, United States
Mount Sinai Comprehensive Cancer Center Aventura
Aventura Florida, 33180, United States
Memorial Healthcare System Office of Human Research
Hollywood Florida, 33021, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
UF Health Cancer Center at Orlando Health
Orlando Florida, 32806, United States
Gwinnett Hospital System Center for Cancer Care
Duluth Georgia, 30096, United States
Gwinnett Hospital System Center for Cancer Care
Lawrenceville Georgia, 30046, United States
Gwinnett Hospital System Center for Cancer Care
Snellville Georgia, 30078, United States
Illinois Cancer Care-Bloomington
Bloomington Illinois, 61704, United States
Affiliated Oncologists
Chicago Ridge Illinois, 60415, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago Illinois, 60612, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Cancer Care Specialists of Central Illinois
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Emhurst Memorial Nancy W. Knowles Cancer Center
Elmhurst Illinois, 60126, United States
Illinois Cancer Care-Galesburg
Galesburg Illinois, 61401, United States
Edward Cancer Center
Naperville Illinois, 60540, United States
Illinois Cancer Care-Ottawa
Ottawa Illinois, 61350, United States
Illinois Cancer Care PC
Peoria Illinois, 61615, United States
Illinois Cancer Care-Peru
Peru Illinois, 61354, United States
Edward Cancer Center Plainfield
Plainfield Illinois, 60585, United States
Cancer Care Specialists of Central Illinois-Swansea
Swansea Illinois, 62226, United States
Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd)
Fort Wayne Indiana, 46804, United States
Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza)
Fort Wayne Indiana, 46845, United States
Mercy Medical Center Hall-Perrine Cancer Center
Cedar Rapids Iowa, 52403, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Susan B. Allen Memorial Hosptial
El Dorado Kansas, 67042, United States
Cancer Center at Mercy - W. Laurel
Independence Kansas, 67301, United States
Kingman Community Hospital
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
McPherson Center for Health
McPherson Kansas, 67460, United States
Newton Medical Center
Newton Kansas, 67114, United States
Labette Health
Parsons Kansas, 67357, United States
Pratt Regional Medical Center
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Winfield Healthcare Center
Winfield Kansas, 67156, United States
Norton Cancer Institute-Downtown
Louisville Kentucky, 40202, United States
Norton Cancer Institute-Norton Healthcare Pavilion
Louisville Kentucky, 40202, United States
University of Louisville-James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
Baptist Health Louisville; Consultants in Blood Disorders and Cancer
Louisville Kentucky, 40207, United States
Norton Cancer Institute-St Matthews
Louisville Kentucky, 40207, United States
Norton Cancer Institute-Brownsboro
Louisville Kentucky, 40241, United States
Ochsner Medical Center-Kenner
Kenner Louisiana, 70065, United States
West Jefferson Medical Center Cancer Center
Marrero Louisiana, 70072, United States
University Medical Center New Orleans
New Orleans Louisiana, 70112, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Medstar Union Memorial Hospital
Baltimore Maryland, 21218, United States
Harry and Jeanette Weinberg Cancer Center at Franklin Square
Baltimore Maryland, 21237, United States
Maryland Oncology Hematology
Bethesda Maryland, 20817, United States
Maryland Oncology - Hematology Brandywine
Brandywine Maryland, 20613, United States
Maryland Oncology - Hematology PA
Columbia Maryland, 21044, United States
Maryland Oncology - Hematology Frederick
Frederick Maryland, 21702, United States
Meritus Center for Clinical Research
Hagerstown Maryland, 21742, United States
Maryland Oncology - Hematology PA
Lanham Maryland, 20706, United States
Maryland Oncology Hematology
Rockville Maryland, 20850, United States
Capital Hematology Oncology Associates
Silver Spring Maryland, 20904, United States
Holy Cross Hospital
Silver Spring Maryland, 20910, United States
University of Maryland, St. Joseph Medical Center
Towson Maryland, 21204, United States
Maryland Oncology Hematology
Wheaton Maryland, 20902, United States
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center
Pittsfield Massachusetts, 01201, United States
Henry Ford Cancer Institute Brownstown
Brownstown Michigan, 48183, United States
Henry Ford Cancer Institute Macomb Hospital
Clinton Township Michigan, 48038, United States
Henry Ford Medical Center Fairlane
Dearborn Michigan, 48126, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Michigan State University
East Lansing Michigan, 48823, United States
Henry Ford Allegiance Health
Jackson Michigan, 49201, United States
Michigan State University-Breslin Cancer Center
Lansing Michigan, 48910, United States
Henry Ford Medical Center Columbus
Novi Michigan, 48377, United States
Henry Ford Hospital W Bloomfield
West Bloomfield Michigan, 48322, United States
Henry Ford Cancer Institute Wyandotte Hospital
Wyandotte Michigan, 48192, United States
University of Missouri-Ellis Fischel Cancer Center
Columbia Missouri, 65212, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
MD Anderson Cancer Center at Cooper
Voorhees New Jersey, 08043, United States
New York Oncology Hematology PC
Albany New York, 12206, United States
Broome Oncolgy
Binghamton New York, 13905, United States
Broome Oncology
Johnson City New York, 13790, United States
Health Quest Medical Practice
Poughkeepsie New York, 12601, United States
Vassar Brothers Medical Center
Poughkeepsie New York, 12601, United States
RHOA of Cary
Cary North Carolina, 27518, United States
Waverly Hematology Oncology
Cary North Carolina, 27518, United States
Carolinas Medical Center-Levine Cancer Insitute
Charlotte North Carolina, 28204, United States
Levine Cancer Center Institute Pineville
Charlotte North Carolina, 28210, United States
RHOA of Garner
Garner North Carolina, 27529, United States
UNC Regional Physicians Hematology and Oncolgoy
High Point North Carolina, 27262, United States
FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center
Pinehurst North Carolina, 28374, United States
Rex Cancer Center
Raleigh North Carolina, 27607, United States
RHOA of Blue Ridge
Raleigh North Carolina, 27607, United States
RCC of Wakefield
Raleigh North Carolina, 27614, United States
Nash UNC Health Care - Danny Talbott Cancer Center
Rocky Mount North Carolina, 28704, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States
Aultman Alliance Cancer Center
Alliance Ohio, 44601, United States
Aultman Hospital
Canton Ohio, 44710, United States
Aultman Medical Group Hematology and Oncology
Canton Ohio, 44710, United States
The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology
Columbus Ohio, 43210, United States
The Stephanie Speilman Comprehensive Breast Center
Columbus Ohio, 43212, United States
Willamette Valley Cancer Institute and Research Center
Eugene Oregon, 97401, United States
Kaiser Permanente Northwest-Oncology/Hematology
Portland Oregon, 97227, United States
Northwest Cancer Specialists
Tigard Oregon, 97223, United States
UPMC Hillman Cancer Center-Beaver
Beaver Pennsylvania, 15009, United States
UPMC Hillman Cancer Center - Passavant North
Cranberry Township Pennsylvania, 16066, United States
Ephrata Cancer Center
Ephrata Pennsylvania, 17522, United States
Allegheny Cancer Institute St. Vincent
Erie Pennsylvania, 16505, United States
St. Vincent Hospital
Erie Pennsylvania, 16544, United States
UPMC Cancer Center Horizon
Farrell Pennsylvania, 16121, United States
Wellspan Medical Oncology
Gettysburg Pennsylvania, 17325, United States
UPMC Hillman Cancer Center- Mountain View
Greensburg Pennsylvania, 15601, United States
UPMC Cancer Center Greenville
Greenville Pennsylvania, 16125, United States
AHN Cancer Institute at Jefferson
Jefferson Hills Pennsylvania, 15025, United States
Seechler Family Cancer Center
Lebanon Pennsylvania, 17042, United States
Forbes Regional Hospital
Monroeville Pennsylvania, 15146, United States
UPMC Hillman Cancer Center UPMC East-Monroeville
Monroeville Pennsylvania, 15146, United States
UPMC Hillman Cancer Center Norwin
N. Huntingdon Pennsylvania, 15642, United States
UPMC Hillman Cancer Center New Castle
New Castle Pennsylvania, 16105, United States
Allegheny General Hospital
Pittsburgh Pennsylvania, 15212, United States
WPAON at AGH
Pittsburgh Pennsylvania, 15212, United States
WPAON at WPH
Pittsburgh Pennsylvania, 15212, United States
Magee-Women's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Western Pennsylvania Hospital
Pittsburgh Pennsylvania, 15224, United States
UPCI Investigational Drug Services
Pittsburgh Pennsylvania, 15232, United States
UPMC Hillman Cancer Center @ Passavant - HOA
Pittsburgh Pennsylvania, 15237, United States
UPMC Hillman Cancer Center @ Passavant - OHA
Pittsburgh Pennsylvania, 15237, United States
UPMC Hillman Cancer Center-Upper Saint Clair
Pittsburgh Pennsylvania, 15243, United States
UPMC Cancer Center Northwest
Seneca Pennsylvania, 16346, United States
UPMC Hillman Cancer Center - Uniontown
Uniontown Pennsylvania, 15401, United States
UPMC Hillman Cancer Center-Washington
Washington Pennsylvania, 15301, United States
Wexford Health & Wellness Pavilion
Wexford Pennsylvania, 15090, United States
Cancer Care Associates of York
York Pennsylvania, 17403, United States
Wellspan Health-York Cancer Center Oncology Research
York Pennsylvania, 17403, United States
Women's and Infants Hospital
Providence Rhode Island, 02905, United States
Gibbs Cancer Center and Research Institute - Pelham
Greer South Carolina, 29651, United States
Spartanburg Medical Center
Spartanburg South Carolina, 29303, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Avera Cancer Institute-Sioux Falls
Sioux Falls South Dakota, 57105, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Wellmont Cancer Institute
Johnson City Tennessee, 37601, United States
Wellmont Cancer Institute
Kingsport Tennessee, 37660, United States
Dell Seton Medical Center at the University of Texas-Seton Infusion Center
Austin Texas, 72701, United States
Texas Oncology Bedford
Bedford Texas, 76022, United States
Texas Oncology Carrollton
Carrollton Texas, 75010, United States
Texas Oncology - Methodist Dallas Cancer Center
Dallas Texas, 75203, United States
Texas Oncology - Medical City Dallas
Dallas Texas, 75230, United States
Texas Oncology Dallas Presbyterian Hospital
Dallas Texas, 75231, United States
Texas Oncology Denton
Denton Texas, 76201, United States
Texas Oncology Flower Mound
Flower Mound Texas, 75028, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
Harris Health System-Smith Clinic
Houston Texas, 77054, United States
Texas Oncology - McAllen South Second
McAllen Texas, 78503, United States
Texas Oncology Midland Allison Cancer Center
Midland Texas, 79701, United States
Texas Oncology Plano
Plano Texas, 75075, United States
Texas Oncology - The Woodlands
The Woodlands Texas, 77380, United States
Wellmont Medical Associates-Oncology and Hematology
Bristol Virginia, 24201, United States
Virginia Cancer Care Specialist
Leesburg Virginia, 20176, United States
Centra Lynchburg Hematology Oncology
Lynchburg Virginia, 24501, United States
Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center
Mechanicsville Virginia, 23116, United States
Bon Secours St Francis Medical Center
Midlothian Virginia, 23114, United States
Southwest Virginia Regional Cancer Center
Norton Virginia, 24273, United States
Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital
Richmond Virginia, 23226, United States
MRCC Auburn
Auburn Washington, 98001, United States
MRCC Gig Harbor
Gig Harbor Washington, 98335, United States
MRCC Puyallup
Puyallup Washington, 98372, United States
MultiCare Health System
Tacoma Washington, 98405, United States
MultiCare Institute for Research & Innovation
Tacoma Washington, 98405, United States
CAMC Health Education and Research Institute
Charleston West Virginia, 25304, United States
West Virginia University
Morgantown West Virginia, 26506, United States
Aurora Cancer Care-Southern Lakes
Burlington Wisconsin, 53105, United States
Aurora Health Center Fond du Lac
Fond Du Lac Wisconsin, 54937, United States
Aurora Cancer Care-Germantown Health Center
Germantown Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha Wisconsin, 53142, United States
Aurora Cancer Care
Milwaukee Wisconsin, 53209, United States
Aurora Cancer Care-Milwaukee South
Milwaukee Wisconsin, 53215, United States
Aurora St. Lukes Medical Center-Pharmacy Only
Milwaukee Wisconsin, 53215, United States
Aurora West Allis Medical Center
Milwaukee Wisconsin, 53227, United States
Aurora Sinai Medical Center
Milwaukee Wisconsin, 53233, United States
Vince Lombardi Cancer Clinic Oshkosh
Oshkosh Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine Wisconsin, 53406, United States
Vince Lombardi Cancer Clinic Sheboygan
Sheboygan Wisconsin, 53081, United States
Aurora Medical Center in Summit
Summit Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers Wisconsin, 54241, United States
Aurora Cancer Care
Wauwatosa Wisconsin, 53226, United States
CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont
Montréal Quebec, H1T2M, Canada
Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu
Montréal Quebec, H2XOA, Canada
SMBD-Jewish General Hospital (MPSG)
Montréal Quebec, H3T 1, Canada
McGill University Health Centre-Cedars Cancer Centre
Montréal Quebec, H4A3J, Canada
CHU de Quebec-Hospital du Saint-Sacrement
Quebec City Quebec, G1S4L, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1550

Study ID:

NCT03281954

Recruitment Status:

Active, not recruiting

Sponsor:


NSABP Foundation Inc

How clear is this clinincal trial information?

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