Trial information
A Study of Herceptin (Trastuzumab) in Combination Therapy in Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: M77003
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Brief summary: This study will assess the cardiac safety and the efficacy of intravenous Herceptin in combination with epirubicin and cyclophosphamide (E/C), compared to E/C alone, as first-line therapy in anthracycline-naive patients with 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 180.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: trastuzumab[Herceptin]
Primary outcome: 1. Occurrence of cardiotoxicity
Key secondary outcomes: 1. Efficacy: Overall response rate and time to progression. Safety: acute coronary syndrome, acute myocardial infarction, severe rhythm disturbances, and asymptomatic decreases in left ventricular ejection fraction
Inclusion criteria:
- female patients >18 years of age;
- histologically confirmed breast cancer;
- clinically or radiologically confirmed recurrent or metastatic breast cancer;
- HER2 overexpression (for patients included in the Herceptin arms).
Exclusion criteria:
- any previous anti-HER treatment or anthracycline-containing chemotherapy;
- previous cytotoxic chemotherapy for metastasis;
- serious cardiac illness (specified in the protocol).
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:
Croatia
France
Germany
- Berlin
- Bonn
- Göttingen
- Hamburg
- Hannover
- Jena
- Karlsruhe
- Kiel
- Magdeburg
- München
- Münster
- Trier
- Tübingen
- Ulm
- Wiesbaden
Hungary
Russian Federation
- Ekaterinburg
- Kazan
- Moscow
- St Petersburg
United Kingdom
- Epping
- Newcastle upon Tyne
- Truro
