# Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

> **NCT05038735** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Novartis Pharmaceuticals** · enrollment: 234 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Alpelisib
- **DRUG:** Fulvestrant
- **DRUG:** Alpelisib-matching placebo

## Key facts

- **NCT ID:** NCT05038735
- **Lead sponsor:** Novartis Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-12-17
- **Primary completion:** 2027-01-28
- **Final completion:** 2027-02-26
- **Target enrollment:** 234 (ACTUAL)
- **Last updated:** 2026-04-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05038735

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05038735, "Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT05038735. Licensed CC0.

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