A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
521
Specified Dose on Specified days
Specified dose on Specified days
Specified dose on Specified days
Specified dose on Specified days
Specified dose on Specified days
Variable endocrine therapy of investigators choice
Surgery for breast cancer
Local Institution - 0136
Mobile, Alabama, United States
Local Institution - 0052
Greenbrae, California, United States
Local Institution - 0051
Whittier, California, United States
Local Institution - 0182
Stamford, Connecticut, United States
Local Institution - 0150
Jacksonville, Florida, United States
Pathological Complete Response (pCR) Rate
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Time frame: Up to approximately 37 months
Pathological Complete Response (pCR) Rate (PD-L1 >=1%)
pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.
Time frame: Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB)
RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
Time frame: Up to approximately 37 months
Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%
RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.
Time frame: Up to approximately 37 months
Number of Participants With Adverse Events (AEs)
Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)
Number of Participants With Serious Adverse Events (SAEs)
Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)
Number of Participants Who Died
Number of participants who died due to any cause.
Time frame: Up to approximately 41 months
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Local Institution - 0097
Miami, Florida, United States
Local Institution - 0149
Pensacola, Florida, United States
Local Institution - 0120
Tallahassee, Florida, United States
Local Institution - 0054
Athens, Georgia, United States
Local Institution - 0107
Atlanta, Georgia, United States
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