# Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

> **NCT05631795** · PHASE4 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 40 (actual)

## Conditions studied

- Advanced Breast Cancer

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Fulvestrant

## Key facts

- **NCT ID:** NCT05631795
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-08-09
- **Primary completion:** 2025-06-12
- **Final completion:** 2025-06-12
- **Target enrollment:** 40 (ACTUAL)
- **Last updated:** 2026-04-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05631795

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05631795, "Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment". Retrieved via AI Analytics 2026-06-22 from https://api.ai-analytics.org/clinical/NCT05631795. Licensed CC0.

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