Phase 3
Completed N=1,147
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Source: ClinicalTrials.gov NCT01610284 ↗Enrolled (actual)
1,147
Serious AEs
21.6%
Results posted
Jun 2020
Primary outcomePrimary: Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort — 6.9; 5.0; 6.8; 4.5 Months — p=<0.001
◆ Published Evidence
Highly cited
539citations · ~60 / year
Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial.
Summary
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.
Linked Publications (2)
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Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial.
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Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort |
6.9; 5.0; 6.8; 4.5; 6.8; 4.0 | <0.001 sig |
| SECONDARY Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort |
33.2; 30.4; 30.9; 28.9; 33.6; 27.5 | 0.045 sig |
| SECONDARY Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort |
11.8; 7.7; 11.0; 7.8; 10.6; 8.2 | — |
| SECONDARY Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort |
43.8; 42.0; 41.7; 39.6; 40.4; 40.8 | — |
| SECONDARY Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths |
569; 532; 144; 101; 12; 13 | — |
| SECONDARY Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1 |
768.306; 750.767; 988.341; 1082.086; 1099.517; 1081.123 | — |
| SECONDARY Predose Trough Concentration-time Profile of BKM120 in Combination With Fulvestrant Over Time - Pharmacokinetic Analysis Set (PAS) |
733.278; 735.172; 716.414 | — |
| SECONDARY Median Time to Definitive Deterioration of the ECOG Performance Status - Full Analysis Set (FAS) |
24.0; 26.4 | — |
| SECONDARY Health-related Quality of Life (HRQoL):Time to 10% Definitive Deterioration in the Global Health Status/Quality of Life Per EORTC-QLQ-C30 |
7.10; 11.50 | — |
Eligibility Criteria
Key Inclusion Criteria
- Locally advanced or metastatic breast cancer
- HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
- Postmenopausal woman
- A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
- Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
- Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
- Adequate bone marrow and organ function defined by laboratory values
Key Exclusion Criteria
- Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
- More than one prior chemotherapy line for metastatic disease
- Symptomatic brain metastases
- 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 questionnaires
Data sourced from ClinicalTrials.gov (NCT01610284) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.