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drugset / Trial / NCT04524000

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

NCT04524000 ↗

Phase 2 Active not recruiting 24 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast cancer harboring a PIK3CA mutation in Japan, whose disease has progressed on or after aromatase inhibitor (AI) treatment regardless of prior CDK4/6 inhibitor use.

Timeline

Start
2021-01-08
Primary completion
2027-02-26
Completion
2027-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 200 mg Oral
Subject Alpelisib Small molecule 250 mg Oral
Subject Alpelisib Small molecule 300 mg Oral
Background Fulvestrant Small molecule 500 mg Intramuscular

Indications

breast cancer