PALOMA-3
Regimen
- Experimental
- Palbociclib 125 mg daily (3/1 schedule) plus fulvestrant 500 mg (with OFS if premenopausal).
- Control
- Placebo plus fulvestrant 500 mg (with OFS if premenopausal).
Population
Women with HR+/HER2- advanced breast cancer whose disease progressed on prior endocrine therapy, including premenopausal with OFS.
Key finding
PALOMA-3 established palbociclib plus fulvestrant as a standard of care after progression on prior endocrine therapy in HR+/HER2- advanced disease. Included premenopausal women with OFS, extending the CDK4/6 evidence base. Final OS numerically favored palbociclib but missed significance, framing the CDK4/6-class OS debate.
Source: PMID 26030518
Timeline
- Publication: 2015 Jul 16
Guideline citations
- NCCN BREAST