None listed
Conditions
Interventions
Treatment arm 1: BKM120 placebo (oral, 100 mg qd) plus trastuzumab (4mg/kg i.v. load followed by 2mg/kg i.v. weekly) for 6 weeks followed by BKM120 placebo (oral, 80 mg qd) plus trastuzumab plus weekl
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient has provided a signed study Informed Consent Form (ICF) prior to any screening procedure 2. Patient is a female ≥ 18 years of age on the day of consenting to the study 3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4. Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed newly diagnosed early breast cancer >2cm (non-inflammatory) by clinical examination and confirmed by ultrasound or by MRI. 5. Patient has tumor tissue (core biopsy) available for central review of ER, HER2; PIK3CA 6. Patient has centrally confirmed HER2-positive disease as defined by Food and Drug Administration (FDA) guidelines, i.e. - IHC +3 (strong staining for >10% of invasive tumor cells) OR- Fluorescent in situ hybridization (FISH/CISH/SISH ratio >2.0) or an equivalent in situ hybridization (ISH) by central testing OR - HER2 gene amplication by FISH/SISH (>4 HER2 gene copies per nucleus). 7. Patients has PIK3CA gene status confirmed (mutated or wild-type) (patients with mutational status unknown will not be eligible for ths trial) 8. Sentinel node biopsy before inclusion is allowed. Criteria 9 and 10 in section 5.2 in protocol.
Exclusion criteria
Exclusion criteria: 1. Patient has received previous treatment with PI3K inhibitors 2. Patient has a known hypersensitivity or intolerance to trastuzumab, paclitaxel or other products containing cremophor 3. Patient has a contraindication to use trastuzumab, paclitaxel or the paclitaxel standard pre-treatment such as steroids (see section Concomitant medication) 4. Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer 5. Patient has a concurrent malignancy or has had a malignancy in the last 3 years prior to start of study treatment (with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer). 6. Left Ventricular Ejection Fraction (LVEF) below 55% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) 7. Patient has active cardiac disease or a history of cardiac dysfunction including any of the following: • Unstable angina pectoris within 6 months prior to study entry. If a patient has had cardiac revascularization 6 months prior to study entry (e.g. with a stent) and are currently asymptomatic, they are able to be included • Documented myocardial infarction within 6 months prior to study entry • History of documented congestive heart failure (New York Heart Association functional classification III-IV) • Symptomatic pericarditis • Documented cardiomyopathy All exclusion criteria is in section 5.3 in protocol.
Countries
Australia, Austria, Belgium, Brazil, France, Germany, Italy, New Zealand, Singapore, Spain, Switzerland
Contacts
Public ContactDenisse Bretel
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed