TABLE 1.

CDK4/6 inhibitors for the treatment of advanced luminal breast cancer in phase II/III trials.

Clinical trial	Regimen	Phase	Patients	PFS (months)	ORR	Hazard ratio		References
First line
PALOMA-1	Letrozole + palbociclib/Letrozole	Ⅱ	165	10.2 vs. 20.2	39 vs. 55%	0.49		Finn et al. (2015)
PALOMA-2	Letrozole + palbociclib/Letrozole	Ⅲ	666	14.5 vs. 24.8	44 vs. 55%	0.58		Finn et al. (2016)
MONALEESA-2	Letrozole ± ribociclib	Ⅲ	668	14.7 vs. 26.0	37 vs. 53%	0.57		Hortobagyi et al. (2018)
MONARCH-3	NSAI ± abemaciclib	Ⅲ	493	14.7 vs. 28.2	44 vs. 59%	0.54		Goetz et al. (2017)
MONALEESA-7	NSAI/Tamoxifen + OFS ± ribociclib	Ⅲ	672	13.0 vs. 23.8	36 vs. 51%	0.55		Tripathy et al. (2018)
Second line
PALOMA-3	Fulvestrant ± palbociclib	Ⅲ	521	4.6 vs. 9.5	11.1 vs. 25%		0.46	Cristofanilli et al. (2016)
MONARCH-1	Abemaciclib monotherapy	Ⅱ	132	6.0	20%		—	Dickler et al. (2017)
MONARCH-2	Fulvestrant ± abemaciclib	Ⅲ	669	9.3 vs. 16.4	21 vs. 48		0.55	Sledge et al. (2017)
MONALEESA-3	Fulvestrant ± ribociclib	Ⅲ	725	12.8 vs. 20.5	29 vs. 41%		0.59	Slamon et al. (2018)
MONARCH-plus	NSAI ± abemaciclib	Ⅲ	306	14.73 vs. NE	30.3 vs. 56%		0.499	Jiang et al. (2019a)
	Fulvestrant ± ribociclib	Ⅲ	157	5.59 vs. 11.47	7.5 vs. 38.5%		0.376
MONARCH HER	Herceptin + abemaciclib + fulvestrant	Ⅲ	79	8.32 vs. 0.65 vs. 5.69	32.9 vs. 13.9 vs. 13.9%		0.673	Tolaney et al. (2019)
	Herceptin + abemaciclib	Ⅲ	79				0.943
	Herceptin + chemo	Ⅲ	79				—

PFS, progression free survival; NSAI, nonsteroidal aromatase inhibitors; OFS, ovarian function suppression; ORR, objective response rate; NE indicates that the value could not be estimated.