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 (CBYL719A2201)
Phase 2
Completed
- Conditions
- breast cancerHR+ HER2- breast cancer10006291
- Registration Number
- NL-OMON45221
- Lead Sponsor
- ovartis Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
* Postmenopausal women (at time of breast cancer diagnosis) with HR+ HER2- breast cancer, Tc1-T3, M0 operable. See protocol page 49 for details.
* 18 years and above.
* Measurable disease.
* Biopsy available for the analysis of PIK3CA mutation and Ki67 level. Results known.
* ECOG performance status 0-1.
Exclusion Criteria
* Recurrent or metastatic disease.
* Any systemic therapy or radiotherapy for current breast cancer.
* Patients with type 1 diabetes mellitus, or not adequatly type 2 diabetes mellitus.
* Left Ventricular Ejection Fraction < 50%.
* Currently receiving or has received systemic corticosteroids * 2 weeks prior to starting study drug.
* History of acute pancreatitis
* uncontroled hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>pCR. and ORR based on tumor tissue</p><br>
- Secondary Outcome Measures
Name Time Method <p>pCR and ORR based on cDNA, adverse events, breast conserving surgery, Ki67, PK<br /><br>parameters.</p><br>