Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Patient is a female ≥ 18 years of age
Patient has a histologically and/or cytologically confirmed diagnosis of HER2-positive invasive breast cancer with inoperable locally advanced or metastatic disease
Patients with controlled or asymptomatic CNS metastases are eligible
Patient has adequate bone marrow and organ functions, and has recovery from all clinically significant toxicities related to prior anti-neoplastic therapies
Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
Platelets ≥ 100 x 109/L
Hemoglobin (Hgb) ≥ 9.0 g/dL
INR ≤ 2
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or ≤ 5.0 x ULN if liver metastases are present)
Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)
Patient has received prior trastuzumab (alone or in combination) but NO more than 3 prior cytotoxic chemotherapy lines
Prior endocrine and radiotherapy allowed
Patient has ECOG performance status of 0-2 (Phase Ib) or 0-1 (Phase II)
Available tumor tissue (archival or fresh) for biomarker analysis; known PI3K activation status
At least one measurable lesion as per RECIST 1.1
Patient has received prior treatment with a taxane
Patient has "trastuzumab-resistance disease" defined as:
Recurrence while on trastuzumab (or T-DM1) or within 12 months since the last infusion in the adjuvant setting
Progression while on or within 4 weeks since the last infusion of trastuzumab (or T-DM1) in the locally advanced or metastatic setting
You may not be if
Previous treatment with PI3K and/or mTOR inhibitors
Symptomatic/uncontrolled Central Nervous System (CNS) metastases
Concurrent malignancy or malignancy in the last 3 years prior to enrollment
Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF \> 480 msec, 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
Intolerance or contraindications to trastuzumab treatment
Pregnant or nursing (lactating) woman
Prior treatment with capecitabine and lapatinib
Intolerance or contraindications to capecitabine and lapatinib
Previous treatment with HER-2 targeted agents other than trastuzumab or T-DM1
Peripheral neuropathy ≥ Grade 2
Clareo Health | A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
