NCT03386162

SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

SAFIR PI3K is an open-label multicenter phase II randomized trial, comparing alpelisib plus fulvestrant to maintenance chemotherapy in patient PIK3CA mutated with HR+/Her2- metastatic breast cancer who do not present progressive disease after 6-8 cycles of 1st or second line chemotherapy. The primary objective is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival (PFS) compared to maintenance chemotherapy in patients PIK3CA mutated with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who do not present a progressive disease after 6-8 cycles of chemotherapy.

Conditions

• Breast Cancer, PI3K, Alpelisib

Interventions

Type	Name	Description
DRUG	Alpelisib	fulvestrant (500 mg intramuscular \[as two 5 mL injections\] every 28 days ± 3 days, with an additional injection on 15 after the first administration + Alpelisib (300 mg by mouth once daily, in a 21-day cycle). Premenopausal women will receive LH-RH analogs in addition every 28 days ± 3 days.
DRUG	Chemotherapy	maintenance chemotherapy, meaning the same chemotherapy regimen used during the first 6-8 cycles (investigator's choice) or no antineoplastic treatment in case of toxicity after 4 full cycles.

Timeline

• Start date: 2018-03-15
• Primary completion: 2022-11-18
• Completion: 2022-11-18
• First posted: 2017-12-29
• Last updated: 2022-11-28

Locations

14 sites across 1 country: France