Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The purpose of the study was to determine whether treatment with a PI3K inhibitor plus letrozole led to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer.

Key facts

Study ID

NCT01923168

Run by

Novartis Pharmaceuticals

People needed

340

Starts

2014-03-11

Expected to finish

2017-07-08

Last updated by the study team

2018-09-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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
• Uncontrolled hypertension

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• Los Angeles Hematology/Oncology Medical Group Onc Dept. — Los Angeles, California, United States
• University of California at Los Angeles UCLA SC — Los Angeles, California, United States
• University of California San Francisco BYL719A2201 - SC — San Francisco, California, United States
• Emory University School of Medicine/Winship Cancer Institute SC — Atlanta, Georgia, United States
• Mercy Medical Center Medical Oncology & Hematology — Baltimore, Maryland, United States
• Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. BYL719A2201 — Baltimore, Maryland, United States
• Dana Farber Cancer Institute BYL719A2201 — Boston, Massachusetts, United States
• Mayo Clinic - Rochester BYL719A2201 - SC — Rochester, Minnesota, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Duke University Medical Center Duke University Medical Center — Durham, North Carolina, United States
• Northwest Cancer Specialists Vancouver Loc — Portland, Oregon, United States
• Vanderbilt Ingram Cancer Center Vanderbilt Health 100 Oaks — Nashville, Tennessee, United States
• Texas Oncology, P.A. — Bedford, Texas, United States
• Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp — Dallas, Texas, United States
• Texas Oncology Texas Oncology - Sammons — Dallas, Texas, United States
• Texas Oncology Houston Memorial City SC — Houston, Texas, United States
• Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2) — San Antonio, Texas, United States
• Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(5) — San Antonio, Texas, United States
• Virginia Oncology Associates SC — Norfolk, Virginia, United States
• Seattle Cancer Care Alliance SC-3 — Seattle, Washington, United States
• Northwest Medical Specialties Dept.ofNW Med. Specialties — Tacoma, Washington, United States
• Novartis Investigative Site — Kingswood, New South Wales, Australia
• Novartis Investigative Site — Innsbruck, Tyrol, Austria
• University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.