study of sacituzumab govitecan-hziy versus treatment of physician's choice in patients with previously untreated locally advanced inoperable or metastatic triple-negative breast cancer

Conditions: Triple Negative Breast Cancer; PD-L1 Negative

Summary: the primary objective of this study is to compare the progression-free survival (pfs) between sacituzumab govitecan-hziy (sg) versus treatment of physician's choice (tpc) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (pd-l1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (anti-pd-(l)1) agents in the early setting whose tumors do express pd-l1.


Eligibility criteria:
key inclusion criteria: * individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (tnbc) * individuals whose tumors are programmed cell death ligand 1 (pd-l1) negative at screening or individuals whose tumors are pd-l1 positive at screening if they have received an anti-pd-(l)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity * centrally confirmed tnbc and pd-l1 status on fresh or archival tissue * individuals must have completed treatment for stage i-iii breast cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and first documented local or distant disease recurrence * individuals presenting with de novo metastatic tnbc are eligible * measurable disease based on computed tomography (ct) or magnetic resonance imaging (mri) in accordance with per response evaluation criteria in solid tumors (recist) version 1.1. as evaluated locally * eastern cooperative oncology group (ecog) performance status of 0 or 1 * demonstrates adequate organ function * male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception * individuals with human immunodeficiency virus (hiv) must be on antiretroviral therapy (art) and have a well-controlled hiv infection/disease key exclusion criteria: * positive serum pregnancy test or women who are lactating * received systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment * have not recovered from adverse events (aes) due to a previously administered agent at the time study entry * may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. individuals participating in observational studies are eligible * previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor * active second malignancy * active serious infection requiring antibiotics * positive for hiv-1 or 2 with a history of kaposi sarcoma and/or multicentric castleman disease * active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection note: other protocol defined inclusion/exclusion criteria may apply.