# Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer

> **NCT04544189** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 69 (actual)

## Conditions studied

- Breast Neoplasms

## Interventions

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

## Key facts

- **NCT ID:** NCT04544189
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-01-20
- **Primary completion:** 2027-01-29
- **Final completion:** 2027-01-29
- **Target enrollment:** 69 (ACTUAL)
- **Last updated:** 2026-04-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04544189

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04544189, "Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04544189. Licensed CC0.

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