Clinical Trial Protocol Registry

Trial information

A Study of Herceptin (Trastuzumab) in Women With HER2-Positive Advanced and/or Metastatic Breast Cancer

Status:
Completed
Protocol number:
MO16419
Sponsor:
Hoffmann-La Roche AG
Company division:
Pharmaceutical
Official Scientific Title:
A randomized, open-label study of the effect of the combination of Herceptin and Taxotere, with and without Xeloda, on survival in patients with advanced and/or metastatic breast cancer with overexpressed HER2
Brief summary:
This study will assess the efficacy and safety of intravenous (IV) Herceptin in combination with intravenous (iv) docetaxel and oral capecitabine compared with that of Herceptin plus docetaxel in women with previously untreated HER2-positive advanced and/or metastatic breast cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 225.
Study phase:
II
Study type:
Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/efficacy study
Conditions:
  • Breast Cancer
Intervention type:
Drug
Intervention name:
trastuzumab [Herceptin]
Primary outcome:
  1. Efficacy: Overall response rate (complete and partial response)
Key secondary outcomes:
  1. Efficacy: progression-free survival, overall survival. duration of response.Safety: Adverse events, hematologic and biochemical parameters and LVEF
Inclusion criteria:
  • adult, female patients >=18 years of age;
  • untreated HER2-positive advanced and/or metastatic breast cancer;
  • >=1 measurable lesion.
Exclusion criteria:
  • previous treatment with Herceptin or other chemotherapy drugs for advanced/metastatic cancer.
Gender:
Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
December, 2001
Trial registration date:
21.12.2005
Date last updated:
22.01.2010
This trial was conducted at the following locations:
Australia
  • ADELAIDE
  • BRISBANE
  • CAMPERDOWN
  • GEELONG
  • MELBOURNE
  • PERTH
  • SOUTHPORT
Brazil
  • PORTO ALEGRE
  • RIO DE JANEIRO
  • SAO PAULO
Canada
  • CALGARY, AB
  • OTTAWA, ON
  • QUEBEC CITY, QC
Costa Rica
  • SAN JOSE
Finland
  • TURKU
France
  • BESANCON
  • GRENOBLE
  • MARSEILLE
  • PIERRE BENITE
  • RENNES
FRANCE
  • Paris
Greece
  • ATHENS
  • HERAKLION
  • PATRAS
Guatemala
  • GUATEMALA CITY
Italy
  • LEGNAGO
  • NOALE
  • ROZZANO
  • TRENTO
  • TREVIGLIO
Mexico
  • MERIDA
  • MEXICO CITY
  • MONTERREY
Panama
  • PANAMA CITY
Poland
  • GDANSK
  • SZCZECIN
Spain
  • BARCELONA
  • SABADELL
  • ZARAGOZA
SPAIN
  • LERIDA, LERID
Sweden
  • KARLSTAD
  • VÄSTERÅS
United Kingdom
  • IPSWICH
  • LEEDS
  • MANCHESTER
  • NORTHWOOD
  • OXFORD
  • SOUTHAMPTON
  • WESTON SUPER MARE

Link to trial result

For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.

  • Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.

Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.

For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)