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