Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Required: ESR1 expression ≤ 10% (≤ 10%)

estrogen receptor (ER) ≤ 10%

Required: PR (PGR) expression ≤ 10% (≤ 10%)

progesterone receptor (PR) ≤ 10%

Required: HER2 (ERBB2) negative per ASCO/CAP guidelines (IHC and/or ISH) (negative)

human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH))

Excluded: BRCA1 germline mutation

Individuals with germline breast cancer gene (BRCA) mutations

Excluded: BRCA2 germline mutation

Individuals with germline breast cancer gene (BRCA) mutations

Must have received: neoadjuvant therapy — neoadjuvant

residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery

Must have received: surgery — definitive

residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery

Must have received: radiation therapy — adjuvant

Individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment

Cannot have received: stimulatory or coinhibitory T-cell receptor agent (CTLA-4, OX-40, CD137)

Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137))

Cannot have received: HER2-targeted therapy

prior treatment with any HER2-directed agent

Cannot have received: endocrine therapy

Exception: prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment

prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment

Cannot have received: topoisomerase 1 inhibitor

Prior treatment with topoisomerase 1 inhibitors

Cannot have received: antibody-drug conjugate

Exception: containing a topoisomerase inhibitor

Prior treatment with antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor