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

A phase III randomized, double-blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment. - BELLE 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005524-17-BE

Enrollment

1200

Registered

2012-06-27

Start date

2012-08-13

Completion date

Unknown

Last updated

2019-06-30

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

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: 19.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864

Interventions

Product Name: BKM120 Product Code: BKM120 Pharmaceutical Form: Capsule, hard INN or Proposed INN: buparlisib CAS Number: not known Current Sponsor code: BKM120 Concentration unit: mg milligram(s) Conc

Eligibility

Sex/Gender

All

Inclusion criteria

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 hile on after aromatase inhibitor treatment - Measurable disease or non measurable disease bone lesions 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 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260

Exclusion criteria

Exclusion criteria: - Prior chemotherapy for locally advanced or metastatic disease - 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

Design outcomes

Primary

Measure	Time frame
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 • Overall survival (OS) • Overall response rate (ORR) • Clinical benefit rate (CBR) Safety • To characterize the pharmacokinetics of BKM120 given in combination with fulvestrant Patients health related quality of life ;Primary end point(s): To determine whether treatment with PFS in the main study cohort (known PI3K status) regardless of PI3K pathway activation status and/or full population (main study cohort + PI3K unknown cohort) (full population) or PI3K pathway activated sub-population.;Timepoint(s) of evaluation of this end point: every 6 weeks aftre randomisation and then every 8 weeks	—

Measure

Time frame

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 • Overall survival (OS) • Overall response rate (ORR) • Clinical benefit rate (CBR) Safety • To characterize the pharmacokinetics of BKM120 given in combination with fulvestrant Patients health related quality of life ;Primary end point(s): To determine whether treatment with PFS in the main study cohort (known PI3K status) regardless of PI3K pathway activation status and/or full population (main study cohort + PI3K unknown cohort) (full population) or PI3K pathway activated sub-population.;Timepoint(s) of evaluation of this end point: every 6 weeks aftre randomisation and then every 8 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - OS, defined as time from date of randomization to the date of death from any cause - ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as defined in Appendix 6 (RECIST 1.1) - Clinical benefit rate (CBR) is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in Appendix 6 (RECIST 1.1) - Safety: Type, frequency and severity of adverse events per CTCAEv4.03; type, frequency and severity of laboratory toxicities per CTCAEv4.03 - Summary statistics for PK: plasma concentration-time profiles of BKM120 and fulvestrant appropriate PK parameters ;Timepoint(s) of evaluation of this end point: - every 3 months after end of treatment OS - estimated 6 weeks after randomisation ORR - estimated 6 weeks after randomisation CBR - contiuous safety - at each cycle specific days defined in protocol	—

Measure

Time frame

Secondary end point(s): - OS, defined as time from date of randomization to the date of death from any cause - ORR, defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) as defined in Appendix 6 (RECIST 1.1) - Clinical benefit rate (CBR) is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) lasting more than 24 weeks as defined in Appendix 6 (RECIST 1.1) - Safety: Type, frequency and severity of adverse events per CTCAEv4.03; type, frequency and severity of laboratory toxicities per CTCAEv4.03 - Summary statistics for PK: plasma concentration-time profiles of BKM120 and fulvestrant appropriate PK parameters ;Timepoint(s) of evaluation of this end point: - every 3 months after end of treatment OS - estimated 6 weeks after randomisation ORR - estimated 6 weeks after randomisation CBR - contiuous safety - at each cycle specific days defined in protocol

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Countries

Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, Democratic People's Republic of, Korea, Republic of, Netherlands, Peru, Poland, Russian Federation, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Trial Information Desl

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com+41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026