TABLE 1.

Clinical trials with CDK4/6 inhibitors in TNBC obtained from ClinicalTrials.gov

Trial ID	Phase	Arms	Treatment plan	Disease	Primary outcome	Results	Status	REF
	Abemaciclib
NCT03130439	II	Single arm: Abemaciclib	150 mg twice daily for 28 days	Rb‐positive metastatic TNBC	ORR	Awaiting	Recruiting
Patnaik et al.	I	Single arm: Abemaciclib	once daily: 50 mg (n = 4), 100 mg (n = 3), 150 mg (n = 3), or 225 mg (n = 3) Twive daily: 75 mg (n = 3), 100 mg (n = 4), 150 mg (n = 3), 200 mg (n = 7), and 275 mg (n = 3)	TNBC	Safety and tolerability	Median PFS 1.1 months (vs HR+ 8.8 months)		122
	Palbociclib
NCT02605486	I/II	Palbociclib + Bicalutamide	Phase I: to be determined Phase II: bicalutamide orally once daily. Palbociclib will be given orally daily for 3 weeks on followed by 1 week off at the doses determined in phase I	AR‐positive metastatic TNBC	Phase II dose Phase II PFS	Awaiting	Active: not recruiting
DeMichele et al.	II	Single arm: Palbociclib	125 mg for 3 weeks on followed by 1 week off	Rb‐positive metastatic TNBC		Median PFS 1.5 months (vs HR+/Her2−: 3.8 months vs HR+/Her2+: 5.1 months)		120
NCT04360941	I	Palbociclib + Avelumab	Part A: palbociclib dose escalation + fixed dose of avelumab (n = 18) Part B: MTD and schedule determined by plan A.	AR‐positive metastatic TNBC		MTD ORR	Recruiting
	Ribociclib
NCT03090165	I/II	Ribociclib + Bicalutamide	Phase I: cohort 1: bicalutamide 150 mg daily on days 1–28 + ribociclib 400mg daily on days 1–21 of a 28 day cycle cohort 2: bicalutamide 150 mg daily on days 1–28 + ribociclib 400 mg daily on days 1–28 of a 28 day cycle cohort 3: bicalutamide 150 mg daily on days 1–28 + ribociclib 600 mg daily on days 1–21 of a 28 day cycle Phase II: maximum safe dose of ribociclib in combination with bicalutamide (n = 25)	Rb‐positive metastatic TNBC	Phase I MTD Phase II CBR	Awaiting	Recruiting

Abbreviations: ORR, objective response rate; PFS, progression free survival; CBR, clinical benefit rate; MTD, maximum tolerated dose.