A randomized, double-blind, placebo controlled, phase II/III study of BKM120 plus paclitaxel in patients with HER2 negative inoperable locally advanced or metastatic breast cancer, with or without PI3K pathway activation.
- Conditions
- breast cancer10006291
- Registration Number
- NL-OMON39231
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- Breast cancer that is locally advanced or metastatic ;- HER2 negative disease, and a known 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;- Adequate bone marrow and organ function
- Prior chemotherapy for locally advanced or metastatic disease;- Previous treatment with PI3K inhibitors;- Symptomatic brain 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 as defined in the protocol;- Sensitivity to paclitaxel treatment or inability to use the paclitaxel standard pre-treatment such as corticosteroids;- Pregnant or nursing (lactating) woman;- Certain scores on an anxiety and depression mood questionaire given at screening;Other protocol defined criteria may apply
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, Overall response rate, Duration of response, Time to<br /><br>response, Clinical benefit rate, Safety, PK.</p><br>