A phase III study of BKM120 with fulvestrant in postmenopausal patients with hormone receptor + HER2-locally advanced or metatstatic breast cancer refractory to aromatase inhibitors

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.
MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-005524-17-AT

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1200

Inclusion Criteria

- Breast cancer that is locally advanced or metastatic
- HER2 negative disease, hormone receptor positive status (common breast cancer classification tests)
- postmenopausal woman
- A tumor sample must be shipped to novartis designed laboratory for identification of biomarkers (PI3K activation status)
- Progression recurrence of breast cancer while on after aromatase inhibitor treatment
- Measurable disease or non measurable disease bone lesions lytic or mixed in the absence of measurable disease as per RECIST 1.1
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 3

Exclusion Criteria

- Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitors, fulvestrant
- More than one prior chemotherapy line for metastatic disease
- 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
- 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 fulvestrant versus BKM120 matching placebo once daily plus fulvestrant on progression-free survival (PFS) ;Secondary Objective: To evaluate BKM120 once daily plus fulvestrant versus BKM120 matching placebo once daily plus fulvestrant with respect to <br>•Overall survival (OS)<br>•Overall response rate (ORR)<br>•Clinical benefit rate (CBR)<br>Safety<br>•To characterize the pharmacokinetics of BKM120 given in combination with fulvestrant<br>Patients health related quality of life <br>;Primary end point(s): To determine whether treatment with PFS in the main study cohort<br>(known PI3K status) regardless of PI3K pathway activation status<br>and/or full population (main study cohort + PI3K unknown cohort) (full<br>population) or PI3K pathway activated sub-population.;Timepoint(s) of evaluation of this end point: every 6 weeks after randomisation and then every 8 weeks

Secondary Outcome Measures

Name	Time	Method

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