Overview

Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor

Status:
Completed

Trial end date:
2019-04-19

Target enrollment:

Participant gender:

Summary

This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

Phase:

Phase 3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Treatments:

Aromatase Inhibitors
Estradiol
Fulvestrant
Hormones