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
N/A II Rb-positive advanced BC Prior treatment 28 palbociclib 125mg daily;
3 weeks on, 1 week off
7% PR
14% SD
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

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