A study of the experimental drug BKM120 with paclitaxel in patients with HER2 negative, locally advanced or metastatic breast cancer, with or without PI3K activatio

• Conditions: This study will evaluate whether the addition of daily BKM120 to weekly paclitaxel is effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.; MedDRA version: 16.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-005932-24-CZ
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

- 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
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 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival (PFS) ;Secondary Objective: To evaluate BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel with respect to <br>•Overall survival (OS)<br>•Overall response rate (ORR)<br>•Duration of response (DOR)<br>•Time to response<br>•Clinical benefit rate <br>•Safety<br>•To characterize the pharmacokinetics of BKM120 given in combination with paclitaxel<br>;Primary end point(s): PFS in the PI3K pathway activated sub-population and full population.;Timepoint(s) of evaluation of this end point: When a total of 125 PFS events have occurred (about 18-22 months); Estimated average 6-9 months for each patient.