A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Phase 3

Completed

Conditions: breast cancer
10006291

Registration Number: NL-OMON44929

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

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

Exclusion Criteria

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary: PFS based on ctDNA, Overall survival based on ctDNA, Overall<br /><br>response rate based on ctDNA, Clinical benefit rate based on ctDNA, Safety, PK,<br /><br>Quality of life, time to definitive deterioration of the ECOG PS of the score<br /><br>of the baseline</p><br>