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

> **NCT03386162** · PHASE2 · TERMINATED · sponsor: **UNICANCER** · enrollment: 31 (actual)

## Conditions studied

- Breast Cancer, PI3K, Alpelisib

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Chemotherapy

## Key facts

- **NCT ID:** NCT03386162
- **Lead sponsor:** UNICANCER
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-03-15
- **Primary completion:** 2022-11-18
- **Final completion:** 2022-11-18
- **Target enrollment:** 31 (ACTUAL)
- **Why stopped:** Study was halted Prematurely for low recruitment.
- **Last updated:** 2022-11-28


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03386162

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03386162, "SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer". Retrieved via AI Analytics 2026-05-30 from https://api.ai-analytics.org/clinical/NCT03386162. Licensed CC0.

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