# 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.

Source: https://onco.cc/trials/nct05038735/  
OnCo record `nct05038735` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Alpelisib and Fulvestrant in HR-positive / HER2-negative breast cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

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. is a phase 3 interventional study registered as NCT05038735 by Novartis Pharmaceuticals, with 210 participants enrolled, started 2021-12-17 and due to reach its primary completion in 2027-01-28. Interventions recorded: Alpelisib, Fulvestrant and Alpelisib-matching placebo.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05038735
- Phase: 3
- Setting: EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 210

## Sources

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

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Alpelisib](https://onco.cc/drugs/alpelisib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/)
- companies: [Advanced Accelerator Applications (Novartis)](https://onco.cc/companies/advanced-accelerator-applications/)

---
JSON: https://onco.cc/api/v1/entities/nct05038735.json