A Phase III study of BKM120 with fulvestrant in patients with HR+,HER2-, AI treated, locally advanced or metastatic breast cancer who progressed on or after mTORi

Phase 1

• Conditions: This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive HER2 negative locally advanced or metastatic breast cancer who progressed on or after mTORi.; MedDRA version: 15.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002571-34-GR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-30
• Last Update Posted: 16 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 615

Inclusion Criteria

Postmenopausal women breast cancer that is locally advanced or metastatic HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization prior treatment with AIs
Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
Adequate bone marrow and organ function
Other protocol defined criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

More than 1 prior chemotherapy given for locally advanced or metastatic disease
Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
Symptomatic CNS metastases
Concurrent malignancy or malignancy within 3 years prior to start of study treatment
Certain drugs or radiation within 2-4 weeks of enrollment - Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
Hypersensitivity to fulvestrant excipients
Certain scores on an anxiety and depression mood questionnaire given at screening
Other protocol defined criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified