. 2016 Jan 21;3(1):2. doi: 10.3390/medicines3010002

Table 1.

Clinical Trials with cell cycle inhibitors in breast cancer [16].

Trials with CDK 4/5 Inhibitors
Study Name/Identifier	Drug(s)/Novel Agent(s)	Study Phase	N	Primary Endpoint	Disease Setting
PALOMA-2 NCT01740427	Letrozole +/− Palbociclib	II	650	PFS	Front-line, advanced/metastatic
PENELOPE-B NCT1864746	Palbociclib + Endocrine	III	800	DFS	Residual disease after neoadjuvant
PEARL NCT02028507	Palbociclib + exemestane vs. capecitabine	III	348	PFS	Metastatic after progression on AI
neoMONARCH NCT02441946	Abemaciclib + Anastrozole vs. abemaciclib vs. anastrozole	II	220	Δ Ki-67 at 2 weeks	Neoadjuvant, Stage I-III
MONARCH NCT2107703	Fulvestrant +/− Abemaciclib	III	630	PFS	Front-line, advanced/metastatic
MONALEESA-3 NCT02422615	Fulvestrant +/− Ribociclib	III	660	PFS	1^st or 2^nd line, advanced/metastatic
PALLAS NCT02513394	Endocrine +/− Palbociclib	III	4600	DFS	Adjuvant, Stage II-III
Trials with CDK aurora kinase inhibitors
Study Name/Identifier	Drug(s)/Novel Agent(s)	Study Phase	N	Primary Endpoint	Disease Setting
2076-CL-005 NCT01639248	ENMD-2076	II	37	CBR	Metastatic TNBC
13-033 NCT02187991	Paclitaxel +/− Alisertib	II	252	TTP	ER+ or −/HER2−, locally recurrent or metastatic

Abbreviations: Δ = change; CBR = clinical benefit rate; DFS = disease free survival; N = number of patients; PFS = progression free survival; TNBC = triple negative breast cancer; TTP = time to progression, CDK = cyclin dependent kinase, AI = aromatase inhibitor, ENMD-2076 = unnamed novel targeted agent.