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: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Aromatase Inhibitors; Estradiol; Fulvestrant; Hormones

Criteria

Key Inclusion Criteria:

• Locally advanced or metastatic breast cancer

• HER2-negative and hormone receptor-positive status (common breast cancer classification tests)

• Postmenopausal woman

• A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)

• Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment

• Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1

• Adequate bone marrow and organ function defined by laboratory values

Key Exclusion Criteria:

• Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant

• More than one prior chemotherapy line for metastatic disease

• Symptomatic brain metastases

• Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent

• Active heart (cardiac) disease as defined in the protocol

• Certain scores on an anxiety and depression mood questionnaires