Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Phase 4 Completed 40 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer (aBC) with a PIK3CA mutation, whose disease had progressed on or after endocrine-based treatment.

Timeline

Start: 2022-08-09
Primary completion: 2025-06-12
Completion: 2025-06-12

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	300 mg	Oral
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Summary

Timeline

Drugs

Indications