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 220.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: 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
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
- Adelaide
- Geelong
- Melbourne
- Perth
- Southport
- Sydney
Brazil
- Porto Alegre
- Rio De Janeiro
Canada
Costa Rica
Finland
France
- Besancon
- Marseille
- Paris
- Pierre Benite
- Rennes
Greece
Guatemala
Italy
Mexico
- Merida
- Mexico City
- Monterrey
Panama
Poland
Spain
- Barcelona
- Lleida
- Sabadell
- Zaragoza
Sweden
United Kingdom
- Bristol
- Ipswich
- Leeds
- Manchester
- Northwood
- Oxford
