Breast Cancer Clinical Trial
Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
Summary
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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 81 Locations for this study
Birmingham Alabama, 35294, United States
Fayetteville Arkansas, 72703, United States
Los Angeles California, 90017, United States
Los Angeles California, 90095, United States
San Francisco California, 94115, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02215, United States
Rochester Minnesota, 55905, United States
New Brunswick New Jersey, 08901, United States
Durham North Carolina, 27710, United States
Portland Oregon, 97210, United States
Nashville Tennessee, 37203, United States
Bedford Texas, 76022, United States
Dallas Texas, 75231, United States
Dallas Texas, 75246, United States
Houston Texas, 77024, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98105, United States
Tacoma Washington, 98405, United States
Kingswood New South Wales, 2747, Australia
Innsbruck Tyrol, 6020, Austria
Dornbirn Vorarlberg, 6830, Austria
Leoben , A-870, Austria
Rankweil , A-683, Austria
Salzburg , 5020, Austria
Vienna , A-109, Austria
Villach , 9500, Austria
Wien , A-109, Austria
Edegem Antwerpen, 2650, Belgium
Leuven , 3000, Belgium
Sint Niklaas , 9100, Belgium
Goiania GO, 74605, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Ribeirao Preto SP, 14048, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 03102, Brazil
Shumen , 9700, Bulgaria
Sofia , 1303, Bulgaria
Varna , 9010, Bulgaria
Vancouver British Columbia, V5Z 4, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3T 1, Canada
Quebec , G1S 4, Canada
Medellin Antioquia, , Colombia
Bogota , , Colombia
Olomouc CZE, 775 2, Czechia
Praha , 12808, Czechia
Berlin , 13125, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Kiel , 24105, Germany
Koeln , 51067, Germany
Hong Kong SAR , , Hong Kong
Haifa , 35254, Israel
Ramat Gan , 52656, Israel
Tel Aviv , 64239, Israel
Brescia BS, 25127, Italy
Cremona CR, 26100, Italy
Macerata MC, 62100, Italy
Milano MI, 20141, Italy
Napoli , 80131, Italy
Nagoya-city Aichi, 467-8, Japan
Hiroshima-city Hiroshima, 730-8, Japan
Osaka-city Osaka, 540-0, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Koto-ku Tokyo, 135 8, Japan
Niigata , 951-8, Japan
Ashrafieh , 16683, Lebanon
Beirut , , Lebanon
Saida , 652, Lebanon
Delft , 2625 , Netherlands
Den Haag , 2545 , Netherlands
Leiden , 2300 , Netherlands
Tilburg , 5022 , Netherlands
Sevilla Andalucia, 41017, Spain
Barcelona Catalunya, 08036, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Valencia Comunidad Valenciana, 46010, Spain
La Coruna Galicia, 15006, Spain
San Sebastián Pais Vasco, 20014, Spain
Madrid , 28007, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
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