PALOMA-2

NCT01740427 📎

Regimen

Experimental
Palbociclib 125 mg daily (3/1 schedule) plus letrozole 2.5 mg daily.
Control
Placebo plus letrozole 2.5 mg daily.

Population

Postmenopausal women with HR+/HER2- advanced breast cancer with no prior systemic therapy for advanced disease.

Key finding

PALOMA-2 confirmed the PFS benefit of palbociclib plus letrozole in 1L postmenopausal HR+/HER2- metastatic breast cancer and anchored palbociclib's full FDA approval. OS did not reach significance, which -- together with later negative palbociclib OS data -- contributed to ribociclib and abemaciclib gaining OS-based preferred positioning in NCCN.

Source: PMID 27959613

Timeline

  • Publication: 2016 Nov 17

Guideline citations

  • NCCN BREAST