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
Trial status: Open for Enrollment
Why is this study being done?
The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with Breast cancer
Who is eligible to participate?
1. Patient is an adult, female ≥ 18 years old at the time of informed consent
2. Patient has a histologically and/or cytologically confirmed diagnosis of breast cancer
3. Patient is postmenopausal.
4. Patient has T1c-T3, any N, M0, operable breast cancer
5. Patients must have measurable disease
6. Patient has diagnostic biopsy available for the analysis of PIK3CA mutation and Ki67 level.
7. Patient has estrogen-receptor and/or progesterone positive breast cancer as per local laboratory testing
8. 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
1. Patient has locally recurrent or metastatic disease
2. Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current breast cancer disease before study entry.
3. Patient with clinically manifest diabetes mellitus (fasting glucose > 120 mg/dl or 6.7 mmol/L), or documented steroid induced diabetes mellitus
4. Certain scores on an anxiety and depression mood questionnaires
5. Other protocol-defined inclusion/exclusion criteria may apply