Table 1  Summary of current trials with a CDK4/6 inhibitor in advanced treatment settings.

Trial	Combined partner	Focused on	Enrolment from to (n)	PFS 95%-CI	OS 95%-CI	median FU primary OS analysis	OS § 95% CI	median FU longest OS analysis §	References
* Prior chemotherapy allowed in advanced treatment setting. ** The analysis of the longest OS available is also the primary analysis. § If the long-term follow-up analyses are not the primary analyses, they must be considered exploratory. NA = not applicable (not published yet)
MONALEESA-2	Ribociclib Letrozol	Pt. w/o endocrine resistance (first-line)	02/2014 – 03/2015 (n = 668)	0.56 (0.43 – 0.72)	0.76 (0.63 – 0.93)	80	0.76 **(0.63 – 0.93)	80**	6 ,  43 ,  44
MONARCH 3	Abemacliclib Aromatase inhibitor	Pt. w/o endocrine resistance (first-line)	11/2014 – 11/2015 (n = 493)	0.54 (0.41 – 0.72)	Yet unknown	NA	NA	NA	45
PALOMA-2	Palbociclib Letrozol	Pt. w/o endocrine resistance (first-line)	02/2013 – 07/2014 (n = 666)	0.58 (0.46 – 0.72)	Yet unknown	NA	NA	NA	46
MONALEESA-7	Ribociclib Premenopausal endocrine therapy	Pt. w/o endocrine resistance (first-line)*	12/2014 – 08/2016 (n = 672)	0.55 (0.44 – 0.69)	0.71 (0.54 – 0.95)	34.6	0.76 (0.61 – 0.96)	53.5	47 ,  48
MONALEESA-3	Ribociclib Fulvestrant	Pt. with and w/o endocrine resistance	06/2015 – 06/2016 (n = 726)	0.593 (0.48 – 0.73)	0.72 (0.57 – 0.92)	39.4	0.73 (0.59 – 0.90)	56.3	49 ,  50
MONARCH 2	Abemaciclib Fulvestrant	Pt. with endocrine resistance	08/2014 – 12/2015 (n = 669)	0.553 (0.45 – 0.68)	0.757 (0.61 – 0.95)	47.7	0.757 ** (0.61 – 0.95)	47.7**	51 ,  52
PALOMA-3	Palbociclib Fulvestrant	Pt. with endocrine resistance	10/2013 – 08/2014 (n = 521)	0.46 (0.36 – 0.59)	0.81 (0.64 – 1.03)	44.8	0.81 (0.65 – 0.99)	73.3	43 ,  44
DAWNA-1	Dalpiciclib	Pt. with endocrine resistance	unknown (n = 361)	0.45 (0.32 – 0.64)	NA	NA	NA	NA