PADA-1

NCT03079011 📎

Regimen

Experimental
Switch AI to fulvestrant 500 mg while continuing palbociclib.
Control
Continue AI plus palbociclib until radiographic progression.

Population

Postmenopausal women with HR+/HER2- advanced breast cancer on 1L AI plus palbociclib, without radiographic progression, whose ctDNA monitoring detected an emerging ESR1 mutation.

Key finding

PADA-1 was the first trial to show that ctDNA-guided pre-emptive switching of the AI to fulvestrant (with continued palbociclib) on ESR1 emergence nearly doubles PFS, providing proof-of-concept later confirmed by SERENA-6 with an oral SERD.

Source: PMID 36183733

Timeline

  • Publication: 2022 Nov

Guideline citations

  • NCCN BREAST