Clinical trial · Interventional
A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
NCT01572727CI-TRIAL-00026363BELLE-4completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.
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 |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BKM120 and paclitaxel
- description
- Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.
- interventionNames
- Drug: Paclitaxel
- Drug: BKM120
- type
- ACTIVE_COMPARATOR
- label
- Placebo and paclitaxel
- description
- Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.
- interventionNames
- Drug: Paclitaxel
- Drug: BKM120 matching placebo
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer that is locally advanced or metastatic * HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests) * A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization * Adequate bone marrow and organ function * Measurable or non-measurable disease Exclusion Criteria: * Prior chemotherapy for locally advanced or metastatic disease * Previous treatment with PI3K or AKT inhibitors * Patient has symptomatic CNS metastases * Concurrent malignancy or malignancy within 3 years of study enrollment * Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug * Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent * Active heart (cardiac) disease as defined in the protocol * Known hypersensitivity or contraindications to use paclitaxel * Pregnant or nursing (lactating) woman * Certain scores on an anxiety and depression mood questionaire given at screening * Other protocol defined criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.