GW572016 With Docetaxel and Trastuzumab for the Treatment Of Untreated ErbB2 Over-Expressing Metastatic Breast Cancer

PHASE1TerminatedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

September 26, 2005

Primary Completion Date

June 10, 2010

Study Completion Date

June 22, 2022

Conditions
Neoplasms, Breast
Interventions
DRUG

lapatinib, docetaxel, trastuzumab

The phase I part of the study will include cohorts of 3 patients to investigate doses of lapatinib (750mg, 1000mg, 1250mg, 1500mg) with 75mg/m2 3- weekly docetaxel plus standard weekly doses of trastuzumab with prophylactic use of growth factors in all patients. Further cohorts may be explored with prophylactic use of growth factors at the doses stipulated in the phase I dose escalation schema

Trial Locations (5)

4

Novartis Investigative Site, Dublin

8

Novartis Investigative Site, Dublin

37203

Novartis Investigative Site, Nashville

75248

Novartis Investigative Site, Paris

75475

Novartis Investigative Site, Paris

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY