A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Breast Cancer
Interventions
DRUG

Paclitaxel

intravenous paclitaxel 80 mg/m2 per week given until progression

DRUG

BKM120 matching placebo

"Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.~Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area."

DRUG

BKM120

Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

Trial Locations (112)

1134

Novartis Investigative Site, Budapest

1340

Novartis Investigative Site, Ottignies

2060

Novartis Investigative Site, Sydney

2196

Novartis Investigative Site, Johannesburg

2610

Novartis Investigative Site, Wilrijk

3050

Novartis Investigative Site, Parkville

3220

Novartis Investigative Site, Geelong

4000

Novartis Investigative Site, Liège

4032

Novartis Investigative Site, Debrecen

5020

Novartis Investigative Site, Salzburg

6000

Novartis Investigative Site, Charleroi

6009

Novartis Investigative Site, Nedlands

9100

Novartis Investigative Site, Sint-Niklaas

10048

Novartis Investigative Site, Taipei

12180

New York Oncology Hematology, P.C. Dept. of New York Oncology. PC, Troy

13273

Novartis Investigative Site, Marseille

14004

Novartis Investigative Site, Córdoba

15009

Novartis Investigative Site, A Coruña

16132

Novartis Investigative Site, Genova

20141

Novartis Investigative Site, Milan

20190

Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA, Reston

20900

Novartis Investigative Site, Monza

23561

Novartis Investigative Site, New Taipei City

28007

Novartis Investigative Site, Madrid

28033

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28040

Novartis Investigative Site, Madrid

29010

Novartis Investigative Site, Málaga

30060

Northwest Georgia Oncology Center NW Georgia Onc, Marietta

30322

Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2), Atlanta

31059

Novartis Investigative Site, Toulouse

33076

Novartis Investigative Site, Bordeaux

33305

Novartis Investigative Site, Kuei-Shan Chiang

33612

H. Lee Moffitt Cancer Center & Research Institute SC, Tampa

36043

Novartis Investigative Site, Fulda

38320

Novartis Investigative Site, San Cristóbal de La Laguna

40202

Norton Healthcare, Inc., Louisville

41013

Novartis Investigative Site, Seville

43210

Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1, Columbus

44100

Novartis Investigative Site, Cona

44805

Novartis Investigative Site, Saint-Herblain

46009

Novartis Investigative Site, Valencia

46010

Novartis Investigative Site, Valencia

49055

Novartis Investigative Site, Angers

50009

Novartis Investigative Site, Zaragoza

53111

Novartis Investigative Site, Bonn

55131

Novartis Investigative Site, Mainz

60389

Novartis Investigative Site, Frankfurt

63110

Washington University School of Medicine Regulatory, St Louis

66160

University of Kansas Cancer Center Univ Kansas 2, Kansas City

68198

University of Nebraska Medical Center Unv Nebraska Med Ctr (2), Omaha

72015

Novartis Investigative Site, Le Mans

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

73104

University of Oklahoma Health Sciences Center OUHSC 2, Oklahoma City

75246

Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology, Dallas

75390

University of Texas Southwestern Medical Center Harry Hines, Dallas

78229

Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio

80637

Novartis Investigative Site, München

85224

Ironwood Cancer and Research Centers SC, Chandler

85925

Novartis Investigative Site, La Roche-sur-Yon

87131

University of New Mexico Cancer Research Center Dept of Univ New Mexico, Albuquerque

88214

Novartis Investigative Site, Ravensburg

89081

Novartis Investigative Site, Ulm

91054

Novartis Investigative Site, Erlangen

94010

Novartis Investigative Site, Créteil

94805

Novartis Investigative Site, Villejuif

94904

California Cancer Care Marian Speciality, Greenbrae

97210

Northwest Cancer Specialists Vancouver Loc, Portland

98158

Novartis Investigative Site, Messina

119228

Novartis Investigative Site, Singapore

197022

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

5266202

Novartis Investigative Site, Ramat Gan

6423906

Novartis Investigative Site, Tel Aviv

Unknown

Arizona Oncology Associates Dept of Oncology, Phoenix

Rocky Mountain Cancer Centers RMCC Hale Pkwy, Greenwood Village

Novartis Investigative Site, Hong Kong SAR

Novartis Investigative Site, London

A-1090

Novartis Investigative Site, Vienna

60336-045

Novartis Investigative Site, Fortaleza

01221-020

Novartis Investigative Site, São Paulo

01246-000

Novartis Investigative Site, São Paulo

01317-002

Novartis Investigative Site, São Paulo

H4A 3J1

Novartis Investigative Site, Montreal

656 53

Novartis Investigative Site, Brno

775 20

Novartis Investigative Site, Olomouc

128 08

Novartis Investigative Site, Prague

06189

Novartis Investigative Site, Nice

01307

Novartis Investigative Site, Dresden

H-5000

Novartis Investigative Site, Szolnok

464-8681

Novartis Investigative Site, Nagoya

467-8602

Novartis Investigative Site, Nagoya

135-8550

Novartis Investigative Site, Sapporo

Novartis Investigative Site, Koto

259-1193

Novartis Investigative Site, Isehara

216-8511

Novartis Investigative Site, Kawasaki

241-8515

Novartis Investigative Site, Yokohama

860-8556

Novartis Investigative Site, Kumamoto

537-8511

Novartis Investigative Site, Osaka

540-0006

Novartis Investigative Site, Osaka

565-0871

Novartis Investigative Site, Suita

4819 EV

Novartis Investigative Site, Breda

3075 EA

Novartis Investigative Site, Rotterdam

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

08003

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

M16 9QQ

Novartis Investigative Site, Maidstone

G12 OYN

Novartis Investigative Site, Glasgow - Scotland

CH63 3JY

Novartis Investigative Site, Metropolitan Borough of Wirral

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY