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

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 - BELLE 3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44929

Enrollment

Registered

2012-11-13

Start date

2013-12-11

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Treatment with BKM120 or placebo in combination with fulvestrant.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Progression free survival.	—

Secondary

Measure	Time frame
Secondary: PFS based on ctDNA, Overall survival based on ctDNA, Overall response rate based on ctDNA, Clinical benefit rate based on ctDNA, Safety, PK, Quality of life, time to definitive deterioration of the ECOG PS of the score of the baseline	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)