A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Breast Cancer
Interventions
DRUG

Panobinostat

Participants received escalating doses of panobinostat until the maximum tolerated dose (MTD) was reached. The starting dose of panobinostat i.v. was 10mg/m\^2 at days 1 and 8 during a 21-day treatment cycle. The oral panobinostat starting dose was 20 mg twice weekly.

DRUG

Trastuzumab

Fixed doses of trastuzumab were given in parallel with panobinostat. Trastuzumab i.v. was given weekly according to the instruction in the package insert.

Trial Locations (20)

15232

University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital, Pittsburgh

16132

Novartis Investigative Site, Genova

21034

Novartis Investigative Site, Dijon

21201

VA Maryland Health Care Dept.of GreenbaumCancerCent(3), Baltimore

41100

Novartis Investigative Site, Modena

43210

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

44805

Novartis Investigative Site, Saint-Herblain Cédex

47014

Novartis Investigative Site, Meldola

63141

The Center for Cancer Care and Research, St Louis

69115

Novartis Investigative Site, Heidelberg

75231

Novartis Investigative Site, Paris

80045

University of Colorado Dept. of Univ. of Colorado, Aurora

90095

University of California at Los Angeles, Los Angeles

06856

Norwalk Hospital Dept of Norwalk Hospital (2), Norwalk

V1Y 5L3

Novartis Investigative Site, Kelowna

M5G 2M9

Novartis Investigative Site, Toronto

H3T 1E2

Novartis Investigative Site, Montreal

B15 2TH

Novartis Investigative Site, Birmingham

W12 0HS

Novartis Investigative Site, London

M20 4BX

Novartis Investigative Site, Manchester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY