Clinical trial · Interventional
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Hormone Receptor Positive, HER2 Negative, Metastatic Breast Cancer, With or Without PI3K Activated Pathway
- 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 is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BEZ235 | Drug | Dactolisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BEZ235
- interventionNames
- Drug: BEZ235
Primary outcomes (1)
- measure
- Progression-free survival rate after 16 weeks of treatment
- timeFrame
- 16 weeks after the first BEZ235 administration
Secondary outcomes (5)
- measure
- determine the efficacy of BEZ235 (objective response rate)
- timeFrame
- about 6 months
- measure
- evaluate the clinical benefit rate of BEZ235
- timeFrame
- about 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female ≥ 18 years * ECOG performance status ≤ 2 * Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative) * Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression) * Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer * Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST * Adequate bone marrow and organ function Exclusion Criteria: * Previous treatment with PI3K and/or mTOR inhibitors * Symptomatic Central Nervous System (CNS) metastases * Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment * Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug * Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \< 50%, QTcF \> 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) * Inadequately controlled hypertension * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235 * Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists * History of photosensitivity reactions to other drugs * Pregnant or nursing (lactating) woman Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available