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
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