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Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor2(HER2)Negative Metastatic Breast Cancer(MBC) who have failed at least two prior chemotherapy regimens

Not Enrolling

Trial ID:NCT03901339

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Protocol #:19-225

877-DF-TRIAL (877-338-7425)

Condition(s):Metastatic Breast Cancer


Principal Investigator:Bardia, Aditya

Site Investigator(s):Desai, Neelam,
Tolaney, Sara, M.

Site Research Nurse(s):Ficociello, Samantha,
Kasparian, Elizabeth,
Livesey, Megan,
O'Brien, Joanne,
Rutter, Morgan,
Selland, Britt,

Trial Description:
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

Eligibility Requirements:
Key - Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed
- Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC including:
- At least 1 prior anticancer hormonal treatment.
- At least 1 cyclin-dependent kinase inhibitor 4/6 in the metastatic setting.
- Eligible for one of the chemotherapy options listed in the TPC arm
- Documented disease progression after the most recent therapy
- Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm^3, platelets ≥ 100,000 per mm^3).
- Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula
- Adequate hepatic function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN or 5.0 x IULN)
- 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:
- Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations
- History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality
- Individuals with Gilbert's disease.
- Active serious infection requiring antibiotics
- Individuals with a history of an anaphylactic reaction to irinotecan
- 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.
- Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Protocol #: 19-225

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