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Trial record 1 of 1 for:    A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo
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Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281954
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : November 11, 2019
Sponsor:
Collaborators:
Genentech, Inc.
Hoffmann-La Roche
Information provided by (Responsible Party):
NSABP Foundation Inc

Brief 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.


Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Placebo Drug: Atezolizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Placebo Comparator: Placebo
IV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Drug: Placebo

Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + placebo IV Day 1 every 3 weeks for 4 doses.

Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.

+ placebo IV Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.

Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by placebo IV Day 1 every 3 weeks after surgery until 1 year after the first dose.


Experimental: Atezolizumab
IV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Drug: Atezolizumab

Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + Atezolizumab 1200 mg Day 1 every 3 weeks for 4 doses.

Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.

+ Atezolizumab 1200 mg Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.

Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by Atezolizumab 1200 mg Day 1 every 3 weeks after surgery until 1 year after the first dose.





Primary Outcome Measures :
  1. Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0) [ Time Frame: At the time of surgical resection ]
    The absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy

  2. Event-free survival (EFS) [ Time Frame: From randomization until event, through study follow up to the time target number of events is obtained, up to 5 years ]
    Time from randomization until event


Secondary Outcome Measures :
  1. Pathologic complete response in the breast (ypT0/Tis) [ Time Frame: At time of surgical resection ]
    The absence of any invasive component in the resected breast specimen (nodal material not considered)

  2. Pathologic complete response in the breast and lymph nodes (ypT0 ypN0) [ Time Frame: At time of surgical resection ]
    The absence of any invasive component or DCIS in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy

  3. Positive nodal status conversion rate [ Time Frame: From date of randomization through completion of neoadjuvant chemotherapy, approximately 24 weeks ]
    Percentage of patients clinically node-positive that convert to pathologically node-negative following completion of neoadjuvant chemotherapy

  4. Overall survival (OS) [ Time Frame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years ]
    Time from randomization until death from any cause

  5. Recurrence-free interval (RFI) [ Time Frame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years ]
    Time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes)

  6. Distant disease-free survival (DDFS) [ Time Frame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years ]
    Time from randomization until distant recurrence, death from breast cancer, death from other causes, and second primary invasive cancer (non-breast)

  7. Brain metastases free survival [ Time Frame: From date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years ]
    Time from randomization until documentation of first event brain metastasis or death from any cause. Patients who develop locoregional or distant recurrence outside of the central nervous system as first event will continue to be followed for subsequent development of brain metastases.

  8. Frequency of Adverse Events [ Time Frame: From beginning of study therapy to 90 days after last dose of study therapy ]
    Frequency of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

  9. Frequency of immune Adverse Events of Special Interest [ Time Frame: From beginning of study therapy to 90 days after last dose of study therapy ]
    Frequency of immune adverse events of special interest according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

  10. Cardiac safety lead-in (Troponin-T) [ Time Frame: prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo, approximately 12 weeks ]
    Troponin-T levels in blood prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo

  11. Cardiac safety lead-in (Troponin-T) [ Time Frame: After administration of the 1st dose of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 1st dose of AC/EC ]
    Troponin-T levels in blood after administration of the 1st cycle of AC/EC prior to administration of atezolizumab/placebo

  12. Cardiac safety lead-in (Troponin-T) [ Time Frame: After administration of the 3rd dose (Cycle 3; each cycle is 21 days) of AC/EC prior to administration of atezolizumab/placebo, approximately 1 hour after beginning the 3rd dose of AC/EC ]
    Troponin-T levels in blood after administration of the 3rd cycle of AC/EC prior to administration of atezolizumab/placebo

  13. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF) [ Time Frame: Prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo, at baseline ]
    LVEF levels measured at baseline prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo

  14. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF) [ Time Frame: Prior to the 3rd cycle (each cycle is every 21 days) of AC/EC, approximately 6 weeks after initiation of AC/EC ]
    LVEF levels measured before 3rd cycle of AC/EC

  15. Cardiac safety lead-in (Left ventricular ejection fraction; LVEF) [ Time Frame: Four to 6 weeks after surgery ]
    LVEF levels measured after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281954


Contacts
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Contact: Diana Gosik, RN, BS 412-339-5333 diana.gosik@nsabp.org

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Locations
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United States, Alabama
University of South Alabama Mitchell Cancer Institute Recruiting
Mobile, Alabama, United States, 36604
United States, Alaska
Katmai Oncology Group Recruiting
Anchorage, Alaska, United States, 99508
United States, California
Kaiser Permanente-Anaheim Recruiting
Anaheim, California, United States, 92806
Kaiser Permanente-Baldwin Park Recruiting
Baldwin Park, California, United States, 91706
Kaiser Permanente-Bellflower Recruiting
Bellflower, California, United States, 90706
Arrowhead Regional Medical Center Recruiting
Colton, California, United States, 92324
City of Hope Recruiting
Duarte, California, United States, 91010
Kaiser Permanente-Fontana Recruiting
Fontana, California, United States, 92335
Kaiser Permanente-Harbor City Recruiting
Harbor City, California, United States, 90710
Kaiser Permanente-Irvine Recruiting
Irvine, California, United States, 92618
Kaiser Permanente-Sunset Recruiting
Los Angeles, California, United States, 90027
Kaiser Permanente-West Los Angeles Recruiting
Los Angeles, California, United States, 90034
Kaiser Permanente-Panorama City Recruiting
Panorama City, California, United States, 91402
Kaiser Permanente-Riverside Recruiting
Riverside, California, United States, 92505
Kaiser Permanente Medical Group Recruiting
San Diego, California, United States, 92108
Kaiser Permanente-Zion Recruiting
San Diego, California, United States, 92120
Kaiser Permanente- San Marcos Recruiting
San Marcos, California, United States, 92078
Kaiser Permanente-Woodland Hills Recruiting
Woodland Hills, California, United States, 91367
United States, Florida
Mount Sinai Comprehensive Cancer Center Aventura Recruiting
Aventura, Florida, United States, 33180
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
UF Health Cancer Center at Orlando Health Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Gwinnett Hospital System Center for Cancer Care Recruiting
Duluth, Georgia, United States, 30096
Gwinnett Hospital System Center for Cancer Care Recruiting
Lawrenceville, Georgia, United States, 30046
Gwinnett Hospital System Center for Cancer Care Recruiting
Snellville, Georgia, United States, 30078
United States, Illinois
Illinois Cancer Care-Bloomington Recruiting
Bloomington, Illinois, United States, 61704
John H. Stroger, Jr. Hospital of Cook County Withdrawn
Chicago, Illinois, United States, 60612
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Cancer Care Specialists of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Crossroads Cancer Center Recruiting
Effingham, Illinois, United States, 62401
Emhurst Memorial Nancy W. Knowles Cancer Center Recruiting
Elmhurst, Illinois, United States, 60126
Illinois Cancer Care-Galesburg Recruiting
Galesburg, Illinois, United States, 61401
Edward Cancer Center Recruiting
Naperville, Illinois, United States, 60540
Illinois Cancer Care-Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Illinois Cancer Care PC Recruiting
Peoria, Illinois, United States, 61615
Illinois Cancer Care-Peru Recruiting
Peru, Illinois, United States, 61354
Edward Cancer Center Plainfield Recruiting
Plainfield, Illinois, United States, 60585
Cancer Care Specialists of Central Illinois-Swansea Recruiting
Swansea, Illinois, United States, 62226
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc (W. Jefferson Blvd) Recruiting
Fort Wayne, Indiana, United States, 46804
Fort Wayne Medical Oncology and Hematology Inc (Parkview Plaza) Recruiting
Fort Wayne, Indiana, United States, 46845
United States, Kentucky
Norton Cancer Institute-Downtown Recruiting
Louisville, Kentucky, United States, 40202
Norton Cancer Institute-Norton Healthcare Pavilion Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville-James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Baptist Health Louisville; Consultants in Blood Disorders and Cancer Recruiting
Louisville, Kentucky, United States, 40207
Norton Cancer Institute-St Matthews Recruiting
Louisville, Kentucky, United States, 40207
Norton Cancer Institute-Brownsboro Recruiting
Louisville, Kentucky, United States, 40241
United States, Louisiana
Ochsner Medical Center-Kenner Recruiting
Kenner, Louisiana, United States, 70065
West Jefferson Medical Center Cancer Center Recruiting
Marrero, Louisiana, United States, 70072
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Medstar Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Harry and Jeanette Weinberg Cancer Center at Franklin Square Recruiting
Baltimore, Maryland, United States, 21237
Maryland Oncology Hematology Recruiting
Bethesda, Maryland, United States, 20817
Maryland Oncology Hematology Recruiting
Rockville, Maryland, United States, 20850
Capital Hematology Oncology Associates Recruiting
Silver Spring, Maryland, United States, 20904
Holy Cross Hospital Recruiting
Silver Spring, Maryland, United States, 20910
Maryland Oncology Hematology Recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Berkshire Hematology Oncology Services at Berkshire Medical Center Cancer and Infusion Center Recruiting
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Henry Ford Cancer Institute Brownstown Recruiting
Brownstown, Michigan, United States, 48183
Henry Ford Cancer Institute Macomb Hospital Recruiting
Clinton Township, Michigan, United States, 48038
Henry Ford Medical Center Fairlane Recruiting
Dearborn, Michigan, United States, 48126
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Michigan State University Recruiting
East Lansing, Michigan, United States, 48823
Henry Ford Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Michigan State University-Breslin Cancer Center Recruiting
Lansing, Michigan, United States, 48910
Henry Ford Medical Center Columbus Recruiting
Novi, Michigan, United States, 48377
Henry Ford Hospital W Bloomfield Recruiting
West Bloomfield, Michigan, United States, 48322
Henry Ford Cancer Institute Wyandotte Hospital Recruiting
Wyandotte, Michigan, United States, 48192
United States, Missouri
University of Missouri-Ellis Fischel Cancer Center Recruiting
Columbia, Missouri, United States, 65212
United States, New Jersey
Newark Beth Israel Medical Center Recruiting
Newark, New Jersey, United States, 07112
MD Anderson Cancer Center at Cooper Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Health Quest Medical Practice Recruiting
Poughkeepsie, New York, United States, 12601
Vassar Brothers Medical Center Recruiting
Poughkeepsie, New York, United States, 12601
United States, North Carolina
RHOA of Cary Recruiting
Cary, North Carolina, United States, 27518
Waverly Hematology Oncology Recruiting
Cary, North Carolina, United States, 27518
Carolinas Medical Center-Levine Cancer Insitute Recruiting
Charlotte, North Carolina, United States, 28204
Levine Cancer Center Institute Pineville Recruiting
Charlotte, North Carolina, United States, 28210
RHOA of Garner Recruiting
Garner, North Carolina, United States, 27529
UNC Regional Physicians Hematology and Oncolgoy Recruiting
High Point, North Carolina, United States, 27262
FirstHealth of the Carolinas FirstHealth Outpatient Cancer Center Recruiting
Pinehurst, North Carolina, United States, 28374
Rex Cancer Center Recruiting
Raleigh, North Carolina, United States, 27607
RHOA of Blue Ridge Recruiting
Raleigh, North Carolina, United States, 27607
RCC of Wakefield Recruiting
Raleigh, North Carolina, United States, 27614
United States, North Dakota
Sanford Roger Maris Cancer Center Recruiting
Fargo, North Dakota, United States, 58122
United States, Ohio
Aultman Alliance Cancer Center Recruiting
Alliance, Ohio, United States, 44601
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Aultman Medical Group Hematology and Oncology Recruiting
Canton, Ohio, United States, 44710
The Ohio State University Wexner Medical Center-Investigational Drug Service Oncology Recruiting
Columbus, Ohio, United States, 43210
The Stephanie Speilman Comprehensive Breast Center Recruiting
Columbus, Ohio, United States, 43212
United States, Oregon
Kaiser Permanente Northwest-Oncology/Hematology Recruiting
Portland, Oregon, United States, 97227
United States, Pennsylvania
UPMC Hillman Cancer Center-Beaver Recruiting
Beaver, Pennsylvania, United States, 15009
Ephrata Cancer Center Recruiting
Ephrata, Pennsylvania, United States, 17522
St. Vincent Hospital Recruiting
Erie, Pennsylvania, United States, 16544
Wellspan Medical Oncology Recruiting
Gettysburg, Pennsylvania, United States, 17325
UPMC Hillman Cancer Center- Mountain View Recruiting
Greensburg, Pennsylvania, United States, 15601
AHN Cancer Institute at Jefferson Recruiting
Jefferson Hills, Pennsylvania, United States, 15025
Seechler Family Cancer Center Recruiting
Lebanon, Pennsylvania, United States, 17042
Forbes Regional Hospital Recruiting
Monroeville, Pennsylvania, United States, 15146
UPMC Hillman Cancer Center UPMC East-Monroeville Recruiting
Monroeville, Pennsylvania, United States, 15146
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
WPAON at AGH Recruiting
Pittsburgh, Pennsylvania, United States, 15212
WPAON at WPH Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Magee-Women's Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Western Pennsylvania Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15224
UPCI Investigational Drug Services Recruiting
Pittsburgh, Pennsylvania, United States, 15232
UPMC Hillman Cancer Center @ Passavant - HOA Recruiting
Pittsburgh, Pennsylvania, United States, 15237
UPMC Hillman Cancer Center @ Passavant - OHA Recruiting
Pittsburgh, Pennsylvania, United States, 15237
UPMC Hillman Cancer Center-Upper Saint Clair Recruiting
Pittsburgh, Pennsylvania, United States, 15243
UPMC Hillman Cancer Center - Uniontown Recruiting
Uniontown, Pennsylvania, United States, 15401
UPMC Hillman Cancer Center-Washington Recruiting
Washington, Pennsylvania, United States, 15301
Wexford Health & Wellness Pavilion Recruiting
Wexford, Pennsylvania, United States, 15090
Cancer Care Associates of York Recruiting
York, Pennsylvania, United States, 17403
Wellspan Health-York Cancer Center Oncology Research Recruiting
York, Pennsylvania, United States, 17403
United States, Rhode Island
Women's and Infants Hospital Recruiting
Providence, Rhode Island, United States, 02905
United States, South Carolina
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Cancer Center Oncology Clinic Recruiting
Sioux Falls, South Dakota, United States, 57104
Avera Cancer Institute-Sioux Falls Recruiting
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Wellmont Cancer Institute Recruiting
Johnson City, Tennessee, United States, 37601
Wellmont Cancer Institute Recruiting
Kingsport, Tennessee, United States, 37660
United States, Texas
Dell Seton Medical Center at the University of Texas-Seton Infusion Center Recruiting
Austin, Texas, United States, 72701
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Harris Health System-Smith Clinic Recruiting
Houston, Texas, United States, 77054
United States, Virginia
Wellmont Medical Associates-Oncology and Hematology Recruiting
Bristol, Virginia, United States, 24201
Centra Lynchburg Hematology Oncology Recruiting
Lynchburg, Virginia, United States, 24501
Bon Secours Richmond Community Hospital Medical Oncology Associates at Memorial Regional Medical Center Recruiting
Mechanicsville, Virginia, United States, 23116
Bon Secours St Francis Medical Center Recruiting
Midlothian, Virginia, United States, 23114
Southwest Virginia Regional Cancer Center Recruiting
Norton, Virginia, United States, 24273
Bon Secours Richmond Community Hospital Oncology Associates at St. Mary's Hospital Recruiting
Richmond, Virginia, United States, 23226
United States, Washington
MRCC Auburn Recruiting
Auburn, Washington, United States, 98001
MRCC Gig Harbor Recruiting
Gig Harbor, Washington, United States, 98335
MRCC Puyallup Recruiting
Puyallup, Washington, United States, 98372
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
MultiCare Institute for Research & Innovation Recruiting
Tacoma, Washington, United States, 98405
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Aurora Cancer Care-Southern Lakes Recruiting
Burlington, Wisconsin, United States, 53105
Aurora Health Center Fond du Lac Recruiting
Fond Du Lac, Wisconsin, United States, 54937
Aurora Cancer Care-Germantown Health Center Recruiting
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton Recruiting
Grafton, Wisconsin, United States, 53024
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South Recruiting
Kenosha, Wisconsin, United States, 53142
Aurora Cancer Care Recruiting
Milwaukee, Wisconsin, United States, 53209
Aurora Cancer Care-Milwaukee South Recruiting
Milwaukee, Wisconsin, United States, 53215
Aurora St. Lukes Medical Center-Pharmacy Only Recruiting
Milwaukee, Wisconsin, United States, 53215
Aurora West Allis Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53227
Aurora Sinai Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Vince Lombardi Cancer Clinic Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine Recruiting
Racine, Wisconsin, United States, 53406
Vince Lombardi Cancer Clinic Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Aurora Medical Center in Summit Recruiting
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care Recruiting
Wauwatosa, Wisconsin, United States, 53226
Canada, Quebec
CIUSSS de l'Est-de-l'Ile-de-Montreal-Hopital-Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada, H1T2M4
Centre Hospitalier d'Universite de Montreal CHUM-Hotel Dieu Recruiting
Montréal, Quebec, Canada, H2XOA9
SMBD-Jewish General Hospital (MPSG) Recruiting
Montréal, Quebec, Canada, H3T 1E2
McGill University Health Centre-Cedars Cancer Centre Recruiting
Montréal, Quebec, Canada, H4A3J1
CHU de Quebec-Hospital du Saint-Sacrement Recruiting
Quebec City, Quebec, Canada, G1S4L8
Sponsors and Collaborators
NSABP Foundation Inc
Genentech, Inc.
Hoffmann-La Roche
Investigators
Layout table for investigator information
Principal Investigator: Norman Wolmark, MD NSBP Foundation, Inc.

Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT03281954     History of Changes
Other Study ID Numbers: NSABP B-59/GBG 96-GeparDouze
2017-002771-25 ( EudraCT Number )
MO39875 ( Other Identifier: Genentech, Inc. )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: November 11, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NSABP Foundation Inc:
anti-PD-L1 antibody
TNBC
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Atezolizumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs