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
- 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: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002571-34-HU
- Lead Sponsor
- ovartis Pharma Services AG
- 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)
Patient has adequate tumor tissue for the analysis of PI3K related biomarkers
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
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 <br><br>.<br>;Secondary Objective: Overall survival (OS) (key secondary)<br>Overall response rate (ORR)<br>Clinical benefit rate (CBR)<br>Type, frequency and severity of adverse events<br>Plasma concentration-time profiles of BKM120 - pharmacokinetics (PK)<br>Patient reported outcome for global health status/QoL<br>;Primary end point(s): PFS 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 Secondary end point(s): PFS based on local investigator assessment<br>OS <br>ORR <br>Clinical benefit rate <br>Type, frequency and severity of laboratory toxicities per CTCAEv4.03<br>Plasma concentration-time profiles of BKM120 given in combination with fulvestrant and appropriate individual PK parameters based on population PK model<br>Time to definitive 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30<br>Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30<br>Time to definitive deterioration of the ECOG PS of the score of the baseline<br>;Timepoint(s) of evaluation of this end point: Up to approx. 21 months<br>Up to approx. 5.5 months<br>Up to approx. 5.5 months<br>at minimum at each study visit and up to approx. 8 months <br>C1D1, C1D15, C2D1,C3D1 and C4D1 (a cycle [C] = 4 weeks).<br>C1D1, C2D15, C4D1, then every 8 weeks until discontinuation (a cycle [C] = 4 weeks).<br>