A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer

Inclusion Criteria

• •Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
• •Histologically or cytologically locally confirmed TNBC.
• •Phase 1: Individuals with unresectable, locally advanced or metastatic TNBC who are refractory to or relapsed after at least one prior standard-of-care chemotherapy regimen or systemic therapy given for locally advanced or metastatic disease.
• •Phase 2: Individuals with unresectable, locally advanced or metastatic TNBC who have not received previous systemic therapy for advanced disease.
• •Uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotype status.
• •During Phase 1 safety run-in, individuals must be UGT1A1 wild-type.
• •After Phase 1 safety run-in, individuals with any UGT1A1 genotype may be eligible.
• •Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST Version 1.1 criteria.
• •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• •Adequate hematologic counts within 2 weeks prior to enrollment.
• •Adequate hepatic and renal function.