HER2-positive, newly diagnosed, primary breast cancer MedDRA version: 17.0 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BKM120
Product Code: BKM120
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Buparlisib
Current Sponsor code: BKM120
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is a female = 18 years of age - Patient has an ECOG performance status of 0-1 - Patient has a unilateral (multifocal or multicentric disease allowed), histologically confirmed, newly diagnosed early breast cancer>1.5cm by clinical examination and confirmed by ultrasound or by MRI - Patient has tumor tissue available for central review of ER, HER2 and PI3K status with centrally confirmed HER2-positive disease and known PI3KCA mutation status - Patient has adequate bone marrow, renal and liver function - Patient is able to swallow and retain oral medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient has received previous systemic treatment for the current diagnosed disease - Patient has a known contraindications, hypersensitivity or intolerance to trastuzumab, paclitaxel or products containing cremophor - Patient has bilateral breast cancer or metastatic disease or inflammatory breast cancer - LVEF below 50% as determined by MUGA scan or ECHO - Patient has active cardiac disease or a history of cardiac abnormalities as defined in the protocol - Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 - Patient is currently receiving warfarin or other coumarin derived anti-coagulants - Patient is currently receiving increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agents (standard premedication for paclitaxel and local applications allowed) - Patient is currently receiving treatment with drugs known to be strong inhibitors or inducers of CYP3A - Patient has certain scores on an anxiety and depression mood questionnaires - Pregnant or nursing (lactating) women or patients not willing to apply apply highly effective contraception as defined in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To compare the objective (complete + partial) response rate by ultrasound or MRI at the end of the biological window (after week 6) between the two treatments arms separately for PIK3CA mutant and wild-type cohorts;Primary end point(s): Pathological complete response (pCR) rate;Timepoint(s) of evaluation of this end point: baseline, week 18;Main Objective: To evaluate the pathological complete response (pCR) rate irrespective of lymph node involvement, at the time of surgery in patients with HER2- overexpressing or amplified operable breast cancer randomized to neoadjuvant trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 placebo plus paclitaxel) OR trastuzumab plus BKM120 (followed by trastuzumab plus BKM120 plus paclitaxel) separately for PIK3CA mutant and wild-type cohorts | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall objective clinical response rate at the end of the biologic window and prior to surgery - Efficacy by other CR definitions - pCR and clinical rsponse by hormone receptor status (Estrogene Receptor (ER)+ versus ER-) - Number of patients with node-negative disease at definitive surgery (ypN0) - Rate of breast conserving surgery - ?Safety and tolerability ;Timepoint(s) of evaluation of this end point: baseline, week 18 for all endpoints +week 6 for the ORR comparison at the end of the biologic period | — |
Countries
Australia, Austria, Belgium, Brazil, France, Germany, Italy, New Zealand, Peru, Singapore, Spain, Switzerland, Taiwan, United Kingdom
Contacts
Public ContactDrug Regulatory Affairs
Novartis Pharma GmbH
Outcome results
None listed