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programmed cell death 1 ligand 1
triple-negative breast cancer
adenocarcinoma of the breast
core needle biopsy
her2/neu-negative breast cancer
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.
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;
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
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.
Clinical Study Identifier
NSABP Foundation Inc
Last Modified on
29 November 2020
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