A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive HER2-negative breast cancer.
- Conditions
- neoadjuvant hormone-receptor positive HER2-negative breast cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-001862-41-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 372
--patient has T1c-T3, any N, M0 operable breast cancer
--diagnostic biopsy available for analysis of PIK3CA mutation, ER/PR, HER2 status and Ki67 levels
--estrogen-receptor and/or proesterone positive breast cancer as per local or Novartis central lab test
--HER2 negative breast cancer
--known PIK3CA mutation status
--Ki67 level status determined centrally
--ECOG performance status < or = 1
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
--locally recurrent or metastatic disease
--patient has received any systemic therapy (eg chemo-, targeted- or immuno-therapy) or radio-therapy for current disease
--patient with clinically manifest diabetes mellitus (fasting glucose>140mg/dl or 7.7 mmol.L), or documented steroid induced diabetes mellitus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method