. 2023 Mar 14;15(6):1763. doi: 10.3390/cancers15061763

Table 1.

Efficacy of CDK4/6 inhibitors in hormone receptor-positive, HER2-negative aBC phase III trials (in alphabetical and numerical order; adapted and updated from [27]).

	Study Name	ET Partner	Sample Size	Rando-mization	Median PFS in Months (PFS = Primary Endpoint)					Median OS in Months (OS = Secondary Endpoint)
	Study Name	ET Partner	Sample Size	Rando-mization	with CDK4/6 Inhibitor	without CDK4/6 Inhibitor	HR	95% CI	Statistically Significant as per Protocol	with CDK4/6 Inhibitor	without CDK4/6 Inhibitor	HR	95% CI	Statistically Significant as per Protocol
ET +/− Abemaciclib	MONARCH-2 [24,28]	Fulvestrant	669	2:1	16.4	9.3	0.55	0.45–0.68	yes	45.8	37.3	0.78	0.64–0.96	yes
ET +/− Abemaciclib	MONARCH-3 [23,29]	AI	493	2:1	28.2	14.8	0.54	0.42–0.70	yes	67.1	54.5	0.75	0.58–0.97	Final analys is not reported yet ¹
ET +/− Dalpiciclib	DAWNA-1 [26]	Fulvestrant	361	2:1	13.6 ²	7.7 ²	0.45 ²	0.32–0.64 ²	yes ²	Final analys is not reported yet
ET +/− Dalpiciclib	DAWNA-2 [25]	AI	456	2:1	30.6	18.2	0.51	0.38–0.69	yes	Final analys is not reported yet
ET +/− Palbociclib	PALOMA-2 [18,30]	AI	666	2:1	24.8	14.5	0.58	0.46–0.72	yes	53.9	51.2	0.96	0.78–1.18	no
ET +/− Palbociclib	PALOMA-3 [19,31]	Fulvestrant	521	2:1	9.5	4.6	0.46	0.36–0.59	yes	34.9	28.0	0.81	0.64–1.03	no
ET +/− Ribociclib	MONALEESA-2 [22,32]	AI	668	1:1	25.3	16.0	0.57	0.46–0.70	yes	63.9	51.4	0.76	0.63–0.93	yes
	MONALEESA-3 [21,33]	Fulvestrant	726	2:1	20.5	12.8	0.59	0.48–0.73	yes	53.7	41.5	0.73	0.59–0.90	yes
	MONALEESA-7 [20,34]	OFS plus tamoxifen or AI	672	1:1	23.8	13.0	0.55	0.44–0.69	yes	58.7	48.0	0.76	0.61–0.96	yes

aBC: advanced breast cancer; AI: aromatase inhibitor; CI: confidence interval; ET: endocrine treatment; HR: hazard ratio; OFS: ovarian function suppression; OS: overall survival; PFS: progression-free survival; Tam: Tamoxifen. ¹ An interim analysis has been reported [29]. ² As assessed by an independent review committee.