# Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

> **NCT02437318** · PHASE3 · COMPLETED · sponsor: **Novartis Pharmaceuticals** · enrollment: 572 (actual)

## Conditions studied

- Breast Cancer

## Interventions

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

## Key facts

- **NCT ID:** NCT02437318
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2015-07-23
- **Primary completion:** 2018-06-12
- **Final completion:** 2023-06-09
- **Target enrollment:** 572 (ACTUAL)
- **Last updated:** 2025-02-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02437318

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02437318, "Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT02437318. Licensed CC0.

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