Important phase II & III trials of palbociclib in breast cancer.

Table 1: Important phase II & III trials of palbociclib in breast cancer.

Trial Name	Phase	Eligible patients	Disease setting	Number enrolled	Treatment regimen	Status/Results	NCT number or reference
PALOMA-1	I/II	Postmenopausal, ER+ & HER2- advanced BC	First line	165	Palbociclib^ & letrozole placebo & letrozole	PFS 20.2 months PFS 10.2 months	[8]
N/A	II	Rb-positive advanced BC	Prior treatment	28	palbociclib 125mg daily; 3 weeks on, 1 week off	7% PR 14% SD	[72]
PALOMA-2	III	Postmenopausal, ER+ & HER2- advanced BC	First line	450	palbociclib & letrozole placebo & letrozole	Ongoing, recruitment complete	NCT01740427
PALOMA-3	III	Pre and Postmenopausal, ER+ & HER2- advanced BC*	Prior ET, 2nd line & beyond	521	palbociclib & fulvestrant placebo & fulvestrant	PFS 9.2 months PFS 3.8 months	[10]

N/A: Not applicable, ER+ -Estrogen Receptor Positive, HER2: Human Epidermal Growth Factor Receptor Negative, Rb: Retinoblastoma Protein, BC: Breast cancer, ET: Endocrine Therapy, PFS: Progression Free Survival, SD: Stable Disease, PR: Partial Response, NCT: National Clinical Trials

*Pre and perimenopausal women received goserelin.

^Dosing of palbociclib was 125 mg orally daily; three weeks on and one week off.

Letrozole and fulvestrant were administered per standard care guidelines