Clinical Trials /

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

NCT03281954

Description:

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.

Related Conditions:
  • Breast Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: NSABP B-59/GBG 96-GeparDouze
  • SECONDARY ID: 2017-002771-25
  • SECONDARY ID: MO39875
  • NCT ID: NCT03281954

Conditions

  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
PlaceboPlacebo
AtezolizumabAtezolizumab

Purpose

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.

Detailed 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.

      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 for this study will be 1,520 randomized patients. It is expected that approximately
      760 patients will be randomized by sites in North America and approximately 760 patients, by
      sites in Europe.
    

Trial Arms

NameTypeDescriptionInterventions
PlaceboPlacebo ComparatorIV 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
  • Placebo
AtezolizumabExperimentalIV 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
  • Atezolizumab

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 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.

          -  A pretreatment research core biopsy of the primary tumor must be performed with
             submission of 2 cores for required correlative studies. These specimens will NOT be
             returned to the site.

          -  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. Material from either the diagnostic core biopsy or the
             research biopsy can be used for central testing depending on local preferences and
             standards.

          -  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, 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) 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 ≥ 40 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 cortisol must be obtained within 28 days prior to randomization to
             obtain a baseline value.

          -  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 greater than or equal to 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,
             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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
Time Frame:At the time of surgical resection
Safety Issue:
Description:The absence of any invasive component in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy

Secondary Outcome Measures

Measure:Pathologic complete response in the breast (ypT0/Tis)
Time Frame:At time of surgical resection
Safety Issue:
Description:The absence of any invasive component in the resected breast specimen (nodal material not considered)
Measure:Pathologic complete response in the breast and lymph nodes (ypT0 ypN0)
Time Frame:At time of surgical resection
Safety Issue:
Description:The absence of any invasive component or DCIS in the resected breast specimen and all resected lymph nodes following completion of neoadjuvant therapy
Measure:Positive nodal status conversion rate
Time Frame:From date of randomization through completion of neoadjuvant chemotherapy, approximately 24 weeks
Safety Issue:
Description:Percentage of patients clinically node-positive that convert to pathologically node-negative following completion of neoadjuvant chemotherapy
Measure: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
Safety Issue:
Description:Time from randomization until death from any cause
Measure: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
Safety Issue:
Description:Time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes)
Measure: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
Safety Issue:
Description:Time from randomization until distant recurrence, death from breast cancer, death from other causes, and second primary invasive cancer (non-breast)
Measure: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
Safety Issue:
Description: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.
Measure:Frequency of Adverse Events
Time Frame:From beginning of study therapy to 90 days after last dose of study therapy
Safety Issue:
Description:Frequency of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Measure:Frequency of immune Adverse Events of Special Interest
Time Frame:From beginning of study therapy to 90 days after last dose of study therapy
Safety Issue:
Description:Frequency of immune adverse events of special interest according to the NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Measure: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
Safety Issue:
Description:Troponin-T levels in blood prior to initial dose of AC/EC following completion of carboplatin/paclitaxel co-administered with atezolizumab/placebo
Measure: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
Safety Issue:
Description:Troponin-T levels in blood after administration of the 1st cycle of AC/EC prior to administration of atezolizumab/placebo
Measure: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
Safety Issue:
Description:Troponin-T levels in blood after administration of the 3rd cycle of AC/EC prior to administration of atezolizumab/placebo
Measure:Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
Time Frame:Prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo, at baseline
Safety Issue:
Description:LVEF levels measured at baseline prior to initiation of carboplatin/paclitaxel and atezolizumab/placebo
Measure: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
Safety Issue:
Description:LVEF levels measured before 3rd cycle of AC/EC
Measure:Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
Time Frame:Four to 6 weeks after surgery
Safety Issue:
Description:LVEF levels measured after surgery

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NSABP Foundation Inc

Trial Keywords

  • anti-PD-L1 antibody
  • TNBC

Last Updated

March 28, 2018