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
- Conditions
- Hormone receptor-positive HER2-negative locally advanced or metastatic breast cancerMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002571-34-IT
- Lead Sponsor
- OVARTIS FARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 615
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 XML File Identifier: zXDpqxZ1Gv417ZGcCacrJAlZK3A= Page 18/32 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 369
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 246
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
- Primary Outcome Measures
Name Time Method Main Objective: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full population). To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant, for the PI3K pathway activated sub-population.;Secondary Objective: - Overall survival (OS); - Overall response rate (ORR); - Clinical benefit rate (CBR); - Type, frequency and severity of adverse events; - Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK); - Patient reported outcome for global health status/QoL;Primary end point(s): PFS in the full population and PI3K pathway activated sub-population based on local investigator assessment.;Timepoint(s) of evaluation of this end point: Up to approx. 5.5 months
- Secondary Outcome Measures
Name Time Method