Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
NCT ID: NCT01923168
Last Updated: 2018-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
340 participants
INTERVENTIONAL
2014-03-11
2017-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Alpelisib + Letrozole
Participants took alpelisib 300 mg once daily plus letrozole 2.5 mg once daily.
alpelisib
BYL719 + Letrozole
Buparlisib + Letrozole
Participants took buparlisib 100 mg once daily or 5 days on/2 days off plus letrozole 2.5 mg once daily.
buparlisib
BKM120 + Letrozole
Placebo + Letrozole
Participants took matching Placebo (of alpelisib 300 mg once daily/buparlisib 100 mg once daily or 5 days on/2 days off) plus Letrozole 2.5 mg once daily.
Placebo
Placebo (of BYL719 or BKM120) + Letrozole
Interventions
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alpelisib
BYL719 + Letrozole
buparlisib
BKM120 + Letrozole
Placebo
Placebo (of BYL719 or BKM120) + Letrozole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI
Birmingham, Alabama, United States
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
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Innsbruck, Tyrol, Austria
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Dornbirn, Vorarlberg, Austria
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Leoben, , Austria
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Rankweil, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Villach, , Austria
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Edegem, Antwerpen, Belgium
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Leuven, , Belgium
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Sint-Niklaas, , Belgium
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Goiânia, Goiás, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Shumen, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Medellín, Antioquia, Colombia
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Bogotá, , Colombia
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Olomouc, CZE, Czechia
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Prague, , Czechia
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Berlin, , Germany
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Cologne, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Kiel, , Germany
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Hong Kong SAR, , Hong Kong
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Haifa, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Brescia, BS, Italy
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Cremona, CR, Italy
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Macerata, MC, Italy
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Milan, MI, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Hiroshima, Hiroshima, Japan
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Osaka, Osaka, Japan
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Bunkyo-ku, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Niigata, , Japan
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Saida, , Lebanon
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Delft, , Netherlands
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Leiden, , Netherlands
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The Hague, , Netherlands
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Tilburg, , Netherlands
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Seville, Andalusia, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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A Coruña, Galicia, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
Countries
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References
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Mayer IA, Prat A, Egle D, Blau S, Fidalgo JAP, Gnant M, Fasching PA, Colleoni M, Wolff AC, Winer EP, Singer CF, Hurvitz S, Estevez LG, van Dam PA, Kummel S, Mundhenke C, Holmes F, Babbar N, Charbonnier L, Diaz-Padilla I, Vogl FD, Sellami D, Arteaga CL. A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB). Clin Cancer Res. 2019 May 15;25(10):2975-2987. doi: 10.1158/1078-0432.CCR-18-3160. Epub 2019 Feb 5.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2013-001862-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBYL719A2201
Identifier Type: -
Identifier Source: org_study_id
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