Table 2.

Ongoing Randomized Phase II/III Clinical Trials CDK4/6 Inhibitors in Triple-Negative Breast Cancer

Clinical Trials	Phase	Allocation	Study Population	Number	Arms	Primary Endpoint
NCT04360941	I b	N/A	AR+; TNBC	45	Palbociclib+Avelumab	ORR
NCT03090165	I/II	N/A	AR+; TNBC	11	Ribociclib+Bicalutamide	MTD; CBR
NCT03805399	I/II	Non-randomized	TNBC	140	SHR 6390+SHR 3680	ORR
NCT02978716	II	Randomized	TNBC	102	Trilaciclib+Gemcitabine+Carboplatin	Number of Treatment Related Adverse Event
NCT03519178	1/2A	Non-randomized	TNBC	220	PF-06873600	Number of patients with does limiting toxicities; Safety and tolerability
NCT03756090		Randomized	TNBC	100	Palbociclib+Dose-dense neoadjuvant chemotherapy	pCR
NCT03130439	II	N/A	mTNBC	37	Abemaciclib	ORR
NCT02605486	I/II	N/A	AR+; TNBC		Palbociclib+Bicalutamide	Recommended phase II dose (RP2D) (phase I); PFS (phase II)
NCT03979508		N/A	TNBC	100	Abemaciclib	Proportion of patients who have a CD8/FOXP3 ratio < 1.6
NCT01320592		N/A	mTNBC	9	Palbociclib+Paclitaxel	Adverse Events of PD0332991

Abbreviations: TNBC, triple-negative breast cancer; AR, androgen receptor; mTNBC, metastatic triple-negative breast cancer; ORR, objective response rate; MTD, maximum tolerated dose; CBR, clinical benefit rate; pCR, pathological complete response; SHR 6390, cyclin-dependent kinase inhibitor; PF-06873600, Cyclin-dependent kinase inhibitor; SHR3680, androgen receptor inhibitor.