Trial information
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Status: Recruiting
Protocol number: WO17299
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of first-line Herceptin alone or in combination with a taxane on tumor response and disease progression in patients with metastatic breast cancer who relapsed after receiving adjuvant Herceptin for HER2-positive early breast cancer
Brief summary: This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Target sample size is 40.
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. Tumor response rate and progression Time frame: Event driven
Key secondary outcomes: 1. Duration of response, PFS, time to treatment failure, clinical benefit rate, survival. Time frame: Event driven
2. AEs, hematologic and biochemical parameters, LVEF. Time frame: Throughout study
Inclusion criteria:
- at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
- metastatic breast cancer >=12 months after discontinuation of Herceptin;
- measurable disease.
Exclusion criteria:
- previous chemotherapy for metastatic breast cancer;
- brain metastases;
- invasive malignancy other than metastatic breast cancer.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2005
Trial registration date: 06/24/2005
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
Austria
- Klagenfurt
- Salzburg
- Vöcklabruck
- Wien
Belgium
Brazil
Canada
- Winnipeg, MB
- Brampton, ON
- Oshawa, ON
- Greenfield Park, QC
China
- Beijing
- Guangzhou
- Shanghai
- Wuhan
Germany
- Berlin
- Düsseldorf
- Hamburg
- Köln
- Krefeld
- Lemgo
- München
- Tübingen
Hungary
Italy
- Chieti
- Genova
- Roma
- San Giovanni Rotondo
- Sassari
Panama
Poland
Russian Federation
- Kazan
- Moscow
- St Petersburg
Spain
- Barcelona
- Jaen
- La Coruna
- Madrid
- Valencia
- Zaragoza
Taiwan
