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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/16/2018
Start Date:March 11, 2014
End Date:July 8, 2017

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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

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.


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

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 randomization.

3. Patient with type 1 diabetes mellitus or not adequately controlled type 2 diabetes
mellitus

4. History of acute pancreatitis within 1 year of study entry

5. Uncontrolled hypertension
We found this trial at
24
sites
Atlanta, Georgia 30322
Principal Investigator: Jane M. Meisel
Phone: 404-778-4824
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Baltimore, Maryland 21202
Principal Investigator: David Andrew Riseberg
Phone: +1 410 332 1200
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Baltimore, MD
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Bedford, Texas 76022
Principal Investigator: Thomas C. Anderson
Phone: 817-359-9000
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Bedford, TX
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Birmingham, AL
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Boston, Massachusetts
Principal Investigator: Erica U. Mayer
Phone: 617-632-2335
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Boston, MA
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Dallas, Texas 75231
Principal Investigator: Kristi J. McIntyre
Phone: 214-346-3508
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Dallas, TX
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Dallas, Texas 75246
Principal Investigator: Joyce OShaughnessy
Phone: +1 214 370 1916
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Dallas, TX
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Durham, North Carolina 27710
Principal Investigator: Paul Kelly Marcom
Phone: +1 919 660 1278
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Durham, NC
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Fayetteville, Arkansas 72703
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Fayetteville, AR
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Houston, Texas 77024
Principal Investigator: Frankie Ann Holmes
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Houston, TX
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Kingswood, New South Wales 2747
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Kingswood,
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Los Angeles, California 90017
Principal Investigator: Lasika Seneviratne
Phone: 310-989-7757
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Los Angeles, CA
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Los Angeles, California 90095
Principal Investigator: Sara Hurvitz
Phone: +1 310 582 6324
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Los Angeles, CA
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Nashville, TN
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Norfolk, Virginia 23502
Principal Investigator: Michael A. Danso
Phone: 757-466-8683
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Norfolk, VA
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Portland, Oregon 97210
Principal Investigator: Jay Andersen
Phone: 360-573-1061
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Portland, OR
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Rochester, Minnesota 55901
Principal Investigator: Minetta C. Liu
Phone: 507-266-0539
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Rochester, MN
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San Antonio, Texas 78229
Principal Investigator: Sharon T. Wilks
Phone: 210-656-7177
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San Antonio, TX
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San Antonio, Texas 78229
Principal Investigator: Virginia Kaklamani
Phone: 210-450-1789
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San Francisco, California 94115
Principal Investigator: Hope S. Rugo
Phone: 415-885-3789
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Seattle, Washington 98109
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
Phone: 253-396-5329
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Tacoma, WA
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