Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)

Key Inclusion Criteria:

1. Female or male individuals aged ≥18 years at the time of signing the informed consent form
2. Documented evidence of hormone receptor-positive HER2-negative (HR+/HER2-) MBC confirmed
3. Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC
4. Should have been previously treated with at least 1 taxane in any setting, at least 1 prior anticancer hormonal treatment in any setting
5. Eligible for one of the chemotherapy options listed in the TPC arm
6. Documented radiographic disease progression after the most recent therapy
7. Measurable disease by CT or MRI in accordance with RECIST v 1.1, bone-only disease is not measurable and is not permitted.
8. Adequate bone marrow function, hepatic and renal function
9. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin [ß-hCG]

Key Exclusion Criteria:

1. Previous treatment with Topoisomerase 1 Inhibitors as a free form or as other formulations
2. Individuals who have known brain metastases.
3. Have an active second malignancy within 3 years prior to providing informed consent
4. Individuals with active hepatitis B virus (HBV), or hepatitis C virus infection (measurable viral RNA load with polymerase chain reaction).
5. Active serious infection requiring systemic antibiotic use within 7 days before Cycle1 Day 1.
6. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
7. Known hypersensitivity or intolerance to either of the study treatments or any of the excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.