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

PHASE2CompletedINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

March 11, 2014

Primary Completion Date

July 7, 2017

Study Completion Date

July 8, 2017

Conditions
Breast Cancer
Interventions
DRUG

alpelisib

BYL719 + Letrozole

DRUG

buparlisib

BKM120 + Letrozole

DRUG

Placebo

Placebo (of BYL719 or BKM120) + Letrozole

Trial Locations (86)

652

Novartis Investigative Site, Saida

1303

Novartis Investigative Site, Sofia

2650

Novartis Investigative Site, Edegem

2747

Novartis Investigative Site, Kingswood

3000

Novartis Investigative Site, Leuven

5020

Novartis Investigative Site, Salzburg

6020

Novartis Investigative Site, Innsbruck

6830

Novartis Investigative Site, Dornbirn

9010

Novartis Investigative Site, Varna

9100

Novartis Investigative Site, Sint-Niklaas

9500

Novartis Investigative Site, Villach

9700

Novartis Investigative Site, Shumen

12808

Novartis Investigative Site, Prague

13125

Novartis Investigative Site, Berlin

15006

Novartis Investigative Site, A Coruña

20014

Novartis Investigative Site, Donostia / San Sebastian

20141

Novartis Investigative Site, Milan

21202

Mercy Medical Center Medical Oncology & Hematology, Baltimore

21231

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Johns Hopkins Med. BYL719A2201, Baltimore

23502

Virginia Oncology Associates SC, Norfolk

24105

Novartis Investigative Site, Kiel

25127

Novartis Investigative Site, Brescia

26100

Novartis Investigative Site, Cremona

27710

Duke University Medical Center Duke University Medical Center, Durham

28007

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

30322

Emory University School of Medicine/Winship Cancer Institute SC, Atlanta

37203

Vanderbilt Ingram Cancer Center Vanderbilt Health 100 Oaks, Nashville

41017

Novartis Investigative Site, Seville

45136

Novartis Investigative Site, Essen

46010

Novartis Investigative Site, Valencia

51067

Novartis Investigative Site, Cologne

55905

Mayo Clinic - Rochester BYL719A2201 - SC, Rochester

62100

Novartis Investigative Site, Macerata

64239

Novartis Investigative Site, Tel Aviv

72703

Highlands Oncology Group, Fayetteville

75231

Presbyterian Hospital of Dallas TexasOncology@PresbyterianHosp, Dallas

75246

Texas Oncology Texas Oncology - Sammons, Dallas

76022

Texas Oncology, P.A., Bedford

77024

Texas Oncology Houston Memorial City SC, Houston

78229

Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2), San Antonio

Cancer Therapy & Research Center UT Health Science Center InstituteForDrugDevelopment(5), San Antonio

80131

Novartis Investigative Site, Napoli

90017

Los Angeles Hematology/Oncology Medical Group Onc Dept., Los Angeles

90095

University of California at Los Angeles UCLA SC, Los Angeles

91054

Novartis Investigative Site, Erlangen

94115

University of California San Francisco BYL719A2201 - SC, San Francisco

97210

Northwest Cancer Specialists Vancouver Loc, Portland

98105

Seattle Cancer Care Alliance SC-3, Seattle

98405

Northwest Medical Specialties Dept.ofNW Med. Specialties, Tacoma

166830

Novartis Investigative Site, El Achrafiyé

3525408

Novartis Investigative Site, Haifa

5265601

Novartis Investigative Site, Ramat Gan

35294-0006

University of Alabama at Birmingham/ Kirklin Clinic Univ AL - PI, Birmingham

02215

Dana Farber Cancer Institute BYL719A2201, Boston

08901

Cancer Institute of New Jersey, New Brunswick

A-8700

Novartis Investigative Site, Leoben

A-6830

Novartis Investigative Site, Rankweil

A-1090

Novartis Investigative Site, Vienna

74605-070

Novartis Investigative Site, Goiânia

90610-000

Novartis Investigative Site, Porto Alegre

14048-900

Novartis Investigative Site, Ribeirão Preto

01317-002

Novartis Investigative Site, São Paulo

03102-002

Novartis Investigative Site, São Paulo

V5Z 4E6

Novartis Investigative Site, Vancouver

H2W 1T8

Novartis Investigative Site, Montreal

H3T 1E2

Novartis Investigative Site, Montreal

G1S 4L8

Novartis Investigative Site, Québec

Unknown

Novartis Investigative Site, Medellín

Novartis Investigative Site, Bogotá

Novartis Investigative Site, Hong Kong SAR

Novartis Investigative Site, Beirut

775 20

Novartis Investigative Site, Olomouc

467-8602

Novartis Investigative Site, Nagoya

730-8518

Novartis Investigative Site, Hiroshima

540-0006

Novartis Investigative Site, Osaka

113-8677

Novartis Investigative Site, Bunkyo-ku

135 8550

Novartis Investigative Site, Koto-ku

951-8566

Novartis Investigative Site, Niigata

2625 AD

Novartis Investigative Site, Delft

2300 RC

Novartis Investigative Site, Leiden

2545 CH

Novartis Investigative Site, The Hague

5022 GC

Novartis Investigative Site, Tilburg

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY