Overview

PAlbociclib and Circulating Tumor DNA for ESR1 Mutation Detection

Status:
Active, not recruiting
Trial end date:
2024-04-15
Target enrollment:
Participant gender:
Summary
This study is a randomized, open-label, multicentric, phase III trial conducted in patients receiving aromatase inhibitor and palbociclib as first line therapy for estrogen receptor (ER)-positive HER2-negative metastatic breast cancer and which aims to evaluate, at the onset of ESR1 mutations in circulating tumor DNA, the efficacy of a change of the hormone therapy (aromatase inhibitor (AI) changed to fulvestrant) combined to palbociclib, together with the safety of hormone therapy and palbociclib combination in the overall population.
Phase:
Phase 3
Details
Lead Sponsor:
UNICANCER
Collaborator:
Pfizer
Treatments:
Anastrozole
Aromatase Inhibitors
Estradiol
Exemestane
Fulvestrant
Letrozole
Palbociclib