NCT03560856

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• HR+/HER2-negative Breast Cancer
• Metastasis

Interventions

Type	Name	Description
DRUG	Fulvestrant + palbociclib	Patients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule).

Timeline

• Start date: 2018-06-27
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2018-06-18
• Last updated: 2018-06-18