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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT01923168

Recruitment Status:

Completed

Sponsor:

Novartis Pharmaceuticals

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There are 81 Locations for this study

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University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI
Birmingham Alabama, 35294, United States
Highlands Oncology Group
Fayetteville Arkansas, 72703, United States
Los Angeles Hematology/Oncology Medical Group Onc Dept.
Los Angeles California, 90017, United States
University of California at Los Angeles UCLA SC
Los Angeles California, 90095, United States
University of California San Francisco BYL719A2201 - SC
San Francisco California, 94115, United States
Emory University School of Medicine/Winship Cancer Institute SC
Atlanta Georgia, 30322, United States
Mercy Medical Center Medical Oncology & Hematology
Baltimore Maryland, 21202, United States
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. BYL719A2201
Baltimore Maryland, 21231, United States
Dana Farber Cancer Institute BYL719A2201
Boston Massachusetts, 02215, United States
Mayo Clinic - Rochester BYL719A2201 - SC
Rochester Minnesota, 55905, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Duke University Medical Center Duke University Medical Center
Durham North Carolina, 27710, United States
Northwest Cancer Specialists Vancouver Loc
Portland Oregon, 97210, United States
Vanderbilt Ingram Cancer Center Vanderbilt Health 100 Oaks
Nashville Tennessee, 37203, United States
Texas Oncology, P.A.
Bedford Texas, 76022, United States
Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp
Dallas Texas, 75231, United States
Texas Oncology Texas Oncology - Sammons
Dallas Texas, 75246, United States
Texas Oncology Houston Memorial City SC
Houston Texas, 77024, United States
Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2)
San Antonio Texas, 78229, United States
Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(5)
San Antonio Texas, 78229, United States
Virginia Oncology Associates SC
Norfolk Virginia, 23502, United States
Seattle Cancer Care Alliance SC-3
Seattle Washington, 98105, United States
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma Washington, 98405, United States
Novartis Investigative Site
Kingswood New South Wales, 2747, Australia
Novartis Investigative Site
Innsbruck Tyrol, 6020, Austria
Novartis Investigative Site
Dornbirn Vorarlberg, 6830, Austria
Novartis Investigative Site
Leoben , A-870, Austria
Novartis Investigative Site
Rankweil , A-683, Austria
Novartis Investigative Site
Salzburg , 5020, Austria
Novartis Investigative Site
Vienna , A-109, Austria
Novartis Investigative Site
Villach , 9500, Austria
Novartis Investigative Site
Wien , A-109, Austria
Novartis Investigative Site
Edegem Antwerpen, 2650, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
Novartis Investigative Site
Sint Niklaas , 9100, Belgium
Novartis Investigative Site
Goiania GO, 74605, Brazil
Novartis Investigative Site
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Novartis Investigative Site
Ribeirao Preto SP, 14048, Brazil
Novartis Investigative Site
Sao Paulo SP, 01317, Brazil
Novartis Investigative Site
Sao Paulo SP, 03102, Brazil
Novartis Investigative Site
Shumen , 9700, Bulgaria
Novartis Investigative Site
Sofia , 1303, Bulgaria
Novartis Investigative Site
Varna , 9010, Bulgaria
Novartis Investigative Site
Vancouver British Columbia, V5Z 4, Canada
Novartis Investigative Site
Montreal Quebec, H2W 1, Canada
Novartis Investigative Site
Montreal Quebec, H3T 1, Canada
Novartis Investigative Site
Quebec , G1S 4, Canada
Novartis Investigative Site
Medellin Antioquia, , Colombia
Novartis Investigative Site
Bogota , , Colombia
Novartis Investigative Site
Olomouc CZE, 775 2, Czechia
Novartis Investigative Site
Praha , 12808, Czechia
Novartis Investigative Site
Berlin , 13125, Germany
Novartis Investigative Site
Erlangen , 91054, Germany
Novartis Investigative Site
Essen , 45136, Germany
Novartis Investigative Site
Kiel , 24105, Germany
Novartis Investigative Site
Koeln , 51067, Germany
Novartis Investigative Site
Hong Kong SAR , , Hong Kong
Novartis Investigative Site
Haifa , 35254, Israel
Novartis Investigative Site
Ramat Gan , 52656, Israel
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Brescia BS, 25127, Italy
Novartis Investigative Site
Cremona CR, 26100, Italy
Novartis Investigative Site
Macerata MC, 62100, Italy
Novartis Investigative Site
Milano MI, 20141, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Nagoya-city Aichi, 467-8, Japan
Novartis Investigative Site
Hiroshima-city Hiroshima, 730-8, Japan
Novartis Investigative Site
Osaka-city Osaka, 540-0, Japan
Novartis Investigative Site
Bunkyo-ku Tokyo, 113-8, Japan
Novartis Investigative Site
Koto-ku Tokyo, 135 8, Japan
Novartis Investigative Site
Niigata , 951-8, Japan
Novartis Investigative Site
Ashrafieh , 16683, Lebanon
Novartis Investigative Site
Beirut , , Lebanon
Novartis Investigative Site
Saida , 652, Lebanon
Novartis Investigative Site
Delft , 2625 , Netherlands
Novartis Investigative Site
Den Haag , 2545 , Netherlands
Novartis Investigative Site
Leiden , 2300 , Netherlands
Novartis Investigative Site
Tilburg , 5022 , Netherlands
Novartis Investigative Site
Sevilla Andalucia, 41017, Spain
Novartis Investigative Site
Barcelona Catalunya, 08036, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
La Coruna Galicia, 15006, Spain
Novartis Investigative Site
San Sebastián Pais Vasco, 20014, Spain
Novartis Investigative Site
Madrid , 28007, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

340

Study ID:

NCT01923168

Recruitment Status:

Completed

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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