# 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

Source: https://onco.cc/trials/nct04544189/  
OnCo record `nct04544189` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Alpelisib and Fulvestrant in advanced solid tumours, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

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 is a phase 2 interventional study registered as NCT04544189 by Novartis Pharmaceuticals, with 69 participants enrolled, started 2021-01-20 and due to reach its primary completion in 2027-01-29. Interventions recorded: Alpelisib, Fulvestrant and Placebo.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT04544189
- Phase: 2
- Setting: A Phase II Randomized Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Chinese Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, PIK3CA Mutant Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment, Including a Subset With Pharmacokinetic Analysis
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 69

## Sources

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

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- 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/)

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JSON: https://onco.cc/api/v1/entities/nct04544189.json