# A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

> **NCT04967248** · — · TERMINATED · sponsor: **Novartis Pharmaceuticals** · enrollment: 4 (actual)

## Conditions studied

- Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

## Interventions

- **OTHER:** Alpelisib
- **OTHER:** Fulvestrant

## Key facts

- **NCT ID:** NCT04967248
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** TERMINATED
- **Start date:** 2023-06-21
- **Primary completion:** 2024-10-18
- **Final completion:** 2024-10-18
- **Target enrollment:** 4 (ACTUAL)
- **Why stopped:** Low recruitment
- **Last updated:** 2025-12-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04967248

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04967248, "A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT04967248. Licensed CC0.

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