trial of sacituzumab govitecan in participants with refractory/relapsed metastatic triple-negative breast cancer (tnbc)

Conditions: Breast Cancer

Summary: the primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (tpc) as measured by independently-reviewed independent review committee (irc) progression-free survival (pfs) in participants with locally advanced or metastatic triple-negative breast cancer (tnbc) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.


Eligibility criteria:
key inclusion criteria: * histologically or cytologically confirmed tnbc based on the most recent analyzed biopsy or other pathology specimen. triple negative is defined as \<1% expression for estrogen receptor (er) and progesterone receptor (pr) and negative for human epidermal growth factor receptor 2 (her2) by in-situ hybridization. * refractory to or relapsed after at least two prior standard therapeutic regimens for advanced/metastatic tnbc. * prior exposure to a taxane in localized or advanced/metastatic setting. * eligible for one of the chemotherapy options listed as tpc (eribulin, capecitabine, gemcitabine, or vinorelbine) as per investigator assessment. * eastern cooperative oncology group (ecog) performance score of 0 or 1. * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors version 1.1 (recist 1.1). bone-only disease is not permitted. * at least 2 weeks beyond prior anti-cancer treatment (chemotherapy, endocrine therapy, radiotherapy, and/or major surgery), and recovered from all acute toxicities to grade 1 or less (except alopecia and peripheral neuropathy). * at least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids \< 20 mg prednisone or equivalent daily are permitted provided the dose is stable for 4 weeks). * adequate hematology without ongoing transfusional support (hemoglobin \> 9 g/dl, absolute neutrophil count (anc) \> 1,500 per mm\^3, platelets \> 100,000 per mm\^3). * adequate renal and hepatic function (creatinine clearance \[crcl\] \> 60 ml/min, bilirubin ≤ 1.5 institutional upper limit of normal \[iuln\], aspartate aminotransferase \[ast\] and alanine aminotransferase \[alt\] ≤ 2.5 x iuln or ≤ 5 x iuln if known liver metastases and serum albumin ≥3 g/dl). * recovered from all toxicities to grade 1 or less by national cancer institute common terminology criteria for adverse events (nci ctcae) v4.03 (except alopecia or peripheral neuropathy that may be grade 2 or less) at the time of randomization. participants with grade 2 neuropathy are eligible but may not receive vinorelbine as tpc. * participants with treated, non-progressive brain metastases, off high-dose steroids (\>20 mg prednisone or equivalent) for at least 4 weeks can be enrolled in the trial. key exclusion criteria: * women who are pregnant or lactating. * women of childbearing potential or fertile men unwilling to use effective contraception during study and up to three months after treatment discontinuation in women of child-bearing potential and six months in males post last study drug. * participants with gilbert's disease. * participants with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while participants with other prior malignancies must have had at least a 3-year disease-free interval. * participants known to be human immunodeficiency (hiv) positive, hepatitis b positive, or hepatitis c positive. * infection requiring antibiotic use within one week of randomization. * 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. note: other protocol defined inclusion/exclusion criteria may apply.