The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer
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
Breast CancerBreast Cancer, Pathological Complete Response, neoadjuvant, hormone receptor-positiveLetrozole
You can join if…
Open to females ages 18 years and up
Patient is an adult, female ≥ 18 years old at the time of informed consent
Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
Patient is postmenopausal.
Patient has T1c-T3, any N, M0, operable breast cancer
Patients must have measurable disease
Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
Patient has HER2 negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0 or 1+ as per local laboratory testing
You CAN'T join if...
Patient has locally recurrent or metastatic disease
Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy,immunotherapy) or radiotherapy for current breast cancer disease before randomization.
Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes mellitus
History of acute pancreatitis within 1 year of study entry
Other protocol-defined inclusion/exclusion criteria may apply
University of California San Francisco BYL719A2201 - SC San Francisco, California, 94115, USA
Los Angeles Hematology/Oncology Medical Group Onc Dept. Los Angeles, California, 90017, USA
University of California at Los Angeles UCLA SC Los Angeles, California, 90095, USA