Trial information
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer
Status: No longer recruiting
Protocol number: M77035
Sponsor: F. Hoffmann-La Roche Ltd.
Company division: Pharmaceutical
Official Scientific Title: 'A study of the effect of first line treatment with paclitaxel and Myocet in combination with Herceptin on overall tumor response in patients with metastatic or locally advanced breast cancer and HER2 overexpression.'
Brief summary: This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is
69.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Efficacy: Overall response rate (complete and partial response); Pharmacokinetics: Cmax and AUC.
Key secondary outcomes: 1. Safety: Cardiac contractility, adverse events, laboratory parameters
Inclusion criteria:
- women 18-70 years of age;
- metastatic or locally advanced breast cancer;
- HER2 overexpression;
- >= 1 measurable lesion.
Exclusion criteria:
- prior treatment for advanced breast cancer;
- prior treatment with Herceptin;
- bone or central nervous system metastasis as the only site of disease;
- history of another malignancy (except basal cell skin cancer and cancer in situ of the uterine cervix, and contralateral breast cancer) within 5 years of study.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Anticipated start date: July, 2001
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Spain
