Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
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) in Full Population, Main Study Cohort and PI3K Unknown Cohort
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDCampone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortes J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaer S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. 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. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18. PMID 30241001
- DERIVEDBaselga J, Im SA, Iwata H, Cortes J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. 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. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30. PMID 28576675