Clinical trial · Interventional
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Novartis decided not to pursue further development of buparlisib program (assessment of moderate PFS benefit with know, but manageable, buparlisib profile).
Summary
Brief summary (as posted)
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BKM120 | Drug | Buparlisib | ALIAS |
| BKM120 matching placebo | Drug | — | UNRESOLVED |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BKM120 100mg + Fulvestrant
- description
- BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
- interventionNames
- Drug: Fulvestrant
- Drug: BKM120
- type
- PLACEBO_COMPARATOR
- label
- Placebo + Fulvestrant
- description
- BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
- interventionNames
- Drug: Fulvestrant
- Drug: BKM120 matching placebo
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key inclusion criteria * Female patients age 18 years or older * Histologically and/or cytologically confirmed diagnosis of breast cancer * Radiologic evidence of inoperable locally advanced or metastatic breast cancer * Adequate tumor tissue for the analysis of PI3K-related biomarkers * Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status * Postmenopausal women * Prior treatment with aromatase inhibitors * 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 * ECOG performance status ≤ 2 Key exclusion criteria * Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant * More than one chemotherapy line for metastatic disease * Hypersensitivity to any of the excipients of buparlisib or fulvestrant * Symptomatic central nervous system metastases * Concurrent malignancy or malignancy within 3 years of study enrollment * Certain drugs or radiation within 2-4 weeks of enrollment * Increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent * Certain scores on an anxiety and depression mood questionnaire given at screening * Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus * Active cardiac disease or a history of cardiac dysfunction
References
Publications (1)
- DERIVEDDi Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7. PMID 29223745