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Clinical Trial VICCBRE1393

Title

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

Principal Investigator(s)

Ingrid Mayer

Details

  • Protocol No. VICCBRE1393
  • Open Date: 06/23/2014
  • Staging: Phase II
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the anti-tumor activity of BYL719 QD plus letrozole and buparlisib QD plus letrozole versus letrozole alone in increasing the pathologic complete response (pCR) rate during neo-adjuvant treatment among postmenopausal patients with HR+, HER2-negative breast cancer for each of the two cohorts: i) PIK3CA mutated and ii) PIK3CA wild tumor types.
  • Disease Sites: None Specified
  • Therapies: Chemotherapy - cytotoxic; Hormonal Therapy; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: BYL719; Buparlisib; Letrozole (Femara)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01923168
  • Secondary Protocol No: CBYL719A2201

Description

Patients are being asked to take part in this research study because they have breast cancer. This trial is sponsored by the pharmaceutical company named Novartis. The reason for the study is to learn whether buparlisib and/or BYL719, when added to a standard treatment (letrozole) for your type of breast cancer, helps to control breast cancer before surgery is performed. This study will also help understand what the study treatments do to a patient-s body and assess what your body does to remove the drugs. For this reason, a number of pharmacokinetic (PK) blood samples will be collected in the study, and the blood levels of BYL719, buparlisib and letrozole will be measured. This procedure of collecting blood samples will be offered at some sites and if you are interested in participating in this evaluation please let your study doctor know.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
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
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Exclusion Criteria:
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