Trial information
A Study of Herceptin (Trastuzumab) in Women With c-erbB2-Positive Metastatic Breast Cancer
Status: No longer recruiting
Protocol number: BO16228
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Herceptin added to cyclophosphamide, methotrexate, and 5-fluorouracil on therapeutic activity and incidence of heart failure in women with c-erb2-positive metastatic breast cancer
Brief summary: This study will evaluate the efficacy and safety of Herceptin added to cyclophosphamide, methotrexate and 5-fluorouracil (CMF) in women with c-erbB2-positive 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 85.
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: Objective response rate Safety: Cardiac safety
Key secondary outcomes: 1. Efficacy: Duration of response, time to progression, and toxicity. Safety: Adverse events and laboratory parameters
Inclusion criteria:
- women >=18 years of age;
- histologically proven metastatic breast cancer;
- overexpression of c-erbB2;
- maximum of 1 previous chemotherapy for metastases.
Exclusion criteria:
- previous therapy with an anti-c-erbB2 antibody, including Herceptin;
- patients requiring supportive oxygen therapy.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2002
Trial registration date: 06/24/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:
Belgium
