A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

September 30, 2014

Conditions
Breast Cancer
Interventions
DRUG

LCL161

LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.

DRUG

paclitaxel

"Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment.~iv 80mg/m2"

Trial Locations (50)

9

Novartis Investigative Site, Dublin

112

Novartis Investigative Site, Taipei

6009

Novartis Investigative Site, Nedlands

10002

Novartis Investigative Site, Taipei

13125

Novartis Investigative Site, Berlin

15706

Novartis Investigative Site, Santiago de Compostela

23538

Novartis Investigative Site, Lübeck

24105

Novartis Investigative Site, Kiel

28041

Novartis Investigative Site, Madrid

28050

Novartis Investigative Site, Madrid

33305

Novartis Investigative Site, Kuei-Shan Chiang

33612

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

35100

Novartis Investigative Site, Padua

37232

Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville

40235

Novartis Investigative Site, Düsseldorf

41013

Novartis Investigative Site, Seville

43210

Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State, Columbus

45136

Novartis Investigative Site, Essen

46009

Novartis Investigative Site, Valencia

46010

Novartis Investigative Site, Valencia

60389

Novartis Investigative Site, Frankfurt

65653

Novartis Investigative Site, Brno

69120

Novartis Investigative Site, Heidelberg

72703

Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville

77030

Baylor College of Medicine Dept of Oncology, Houston

78229

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

81675

Novartis Investigative Site, München

90033

Memorial Sloan Kettering Cancer Center Dept Onc, New York

90048

Cedars Sinai Medical Center SC, Los Angeles

90095

University of California at Los Angeles UCLA SC, Los Angeles

91054

Novartis Investigative Site, Erlangen

94304

Stanford University Medical Center Stanford, Stanford

191104

Novartis Investigative Site, Saint Petersburg

197758

Novartis Investigative Site, Saint Petersburg

06520

Yale University School of Medicine Yale Univ, New Haven

02114

Massachusetts General Hospital Mass General 2, Boston

53792-6164

University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 2, Madison

88301-229

Novartis Investigative Site, Itajaí

01317-002

Novartis Investigative Site, São Paulo

01323-900

Novartis Investigative Site, São Paulo

775 20

Novartis Investigative Site, Olomouc

D 79106

Novartis Investigative Site, Freiburg im Breisgau

Unknown

Novartis Investigative Site, Dublin

03080

Novartis Investigative Site, Seoul

05505

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

BN2 5BE

Novartis Investigative Site, Brighton

KT2 7QB

Novartis Investigative Site, Kingston upon Thames

SM2 5PT

Novartis Investigative Site, Sutton

SW3 6JJ

Novartis Investigative Site, London

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY