drugset / Trial / NCT03560856

A Biomarker Study of Palbociclib + Fulvestrant for Second, and Third Line of Postmenopausal Women With hr+/her2- Advanced Breast Cancer

NCT03560856 ↗

Phase 2 Unknown 54 enrolled Assistance Publique - Hôpitaux de Paris
NaSingle-groupOpen-labelTreatment

Summary

The clinical efficacy of fulvestrant and/or palbociclib in the population of patients with metastatic lesions harboring ESR1 mutations was reported. In the PALOMA 3 study, the combination of Fulvestrant+ Palbociclib seems to be active in patients whose tumour harbours ESR1 mutations. This study will confirm these data on this population and will allow us to identify if other gene alterations or a genomic signature can correlate with fulvestrant +palbociclib resistance.

Timeline

Start
2018-06-27
Primary completion
2022-06-01
Completion
2022-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fulvestrant Small molecule 500 mg —
Subject Palbociclib Small molecule 125 mg —