Table 4.

Ongoing clinical trials evaluating sacituzumab govitecan in patients with breast cancer

Register number (target accrual, N)	Design, arms and regimen	Study population	Primary outcome	Status/results
NCT04039230 N = 65	Phase I/II, single arm; sacituzumab govitecan plus talazoparib	Metastatic TNBC	DLT	Accruing
SASCIA NCT04595565 N = 1200	Phase III; open label, randomizing to one of two arms: sacituzumab govitecan vs. TPC	Early-stage TNBC with residual disease following neoadjuvant CT	IDFS	Not yet recruiting
Saci-IO TNBC NCT04468061 N = 110	Phase II, open label; randomizing to one of two arms: sacituzumab govitecan vs. sacituzumab govitecan plus pembrolizumab	Metastatic TNBC. PD-L1 negative (SP142 assay). Treatment naïve in the metastatic setting	PFS	Accruing
Saci-IO HR+ NCT04448886 N = 110	Phase II, open label; randomizing to one of two arms: sacituzumab govitecan vs. sacituzumab govitecan plus pembrolizumab	HR-positive/HER2-negative MBC. PD-L1 positive (CPS ≥10 assessed by 22C3 assay). Progression on or within 12 months of adjuvant ET or have progressed on at least one of ET for metastatic disease	PFS	Accruing
NeoSTAR NCT04230109 N = 50	Phase II; open label, single arm; sacituzumab govitecan monotherapy	Early-stage TNBC, candidate for neoadjuvant therapy	pCR	Accruing
NCT04454437 N = 80	Phase IIb, single arm; sacituzumab govitecan monotherapy	Metastatic TNBC refractory to at least two lines of CT for MBC	ORR	Not yet recruiting
TROPICS-02 NCT03901339 N = 400	Phase III, open label; randomizing to one of two arms: sacituzumab govitecan vs. TPC	HR-positive/HER2-negative refractory to at least two lines of CT for MBC	PFS	Accruing
Morpheus-TNBC NCT03424005 N = 280	Phase Ib/II, open label; randomizing to several cohorts, including one of atezolizumab plus sacituzumab govitecan	Metastatic TNBC	ORR Frequency of AEs	Accruing
SEASTAR NCT03992131 N = 329	Phase Ib/II, open label; with different cohorts including one of sacituzumab govitecan plus rucaparib	Metastatic TNBC	Occurrence of AEs, DLT and ORR (phase II)	Accruing

AE adverse events, CPS combined positive score, CT chemotherapy, DLT dose-limiting toxicity, ET endocrine therapy, HR hormone receptor, IDFS invasive disease-free survival, MBC metastatic breast cancer, ORR objective response rate, pCR pathologic complete response, PFS progression-free survival, TNBC triple-negative breast cancer, TPC treatment of physician’s choice