None listed
Conditions
Interventions
ARM A - Trastuzumab in combination with lapatinib: lapatinib 1000 mg PO once daily plus trastuzumab (loading dose of 8 mg/kg) followed by the maintenance dose of 6 mg/kg IV q3weekly. Weekly trastuzum
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Female 18 years 3. Histologically or cytologially confirmed invasive breast cancer with distant metastasis 4. Subjects must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 5. Documentation of HER2 overexpression or gene amplification, in the invasive component of either the primary tumor or metastatic disease site as defined as: • 3+ by IHC and/or • HER2/neu gene amplification by fluorescence, chromogenic, or silver in situ hybridization [FISH, CISH or SISH;6 HER2/neu gene copies per nucleus or a FISH, CISH, or SISH test ratio (HER2 gene copies to chromosome 17 signals) of ≥2.0 OR HER2/chromosome 17 ratio 2.0 with average HER2 copy number 6 signals/cell nucleus]; 6. Centrally determined HER2-positive, hormone receptor status, breast molecular subtype by PAM50 on the pre-treatment biopsy of metastatic lesion obtained during screening 7. Progression on at least 2 lines of anti-HER2-targeted therapies for MBC 8. Documented radiological disease progression during the most recent treatment regimen for metastatic disease 9. Most recent treatment regimen for metastatic disease must include trastuzumab and chemotherapy. 10. Agreement to provide 2 tumor biopsies
Exclusion criteria
Exclusion criteria: 1. Lactating female 2. Bone-only disease and/or disease that cannot be biopsied. 3. Unstable CNS metastases or leptomeningeal carcinomatosis not considered radiographically stable (as defined above in inclusion criterion 12) 4. Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions including concurrent disease that could interfere with subject’s safety, obtaining informed consent, or compliance with the study procedures. 5. Serious cardiac illness or medical condition including but not confined to: • Uncontrolled arrhythmias (e.g. ventricular tachycardia, high-grade atrioventricular (AV)-block, supraventricular arrhythmias which are not adequately rate-controlled); • Angina pectoris requiring antianginal medication; • History of congestive heart failure or systolic dysfunction (LVEF 160mm Hg or diastolic >100mm Hg); • Clinically significant valvular heart disease. 6. Current active hepatic or biliary disease (with exception of subjects with Gilbert’s syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
Countries
Argentina, Austria, Brazil, Canada, China, Ireland, Italy, Mexico, Netherlands, Peru, Philippines, Portugal, Russian Federation, Spain, Thailand, United States
Contacts
Public ContactPatricia Lopez
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed