Trial information
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Advanced Breast Cancer
Status: No longer recruiting
Protocol number: WO16437
Sponsor: F Hoffman-La Roche Ltd; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of Taxotere and Herceptin, with and without cisplatin or carboplatin, as first-line therapy on time to progression in patients with advanced breast cancer with HER2 NEU alteration
Brief summary: This study will assess the safety and efficacy of Herceptin and docetaxel, with or without carboplatin, in patients with advanced breast cancer and HER2 amplification. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Target sample size is 250.
Study phase: III
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: Time to progression
Key secondary outcomes: 1. Efficacy: Response rate, duration of overall response, complete response, partial response, and survival
Inclusion criteria:
- female patients 18-75 years of age;
- histologically or cytologically proven breast adenocarcinoma at first diagnosis;
- locally advanced or metastatic breast cancer;
- primary or metastatic tumor with HER2 amplification.
Exclusion criteria:
- previous chemotherapy for locally advanced disease, local recurrence, or metastasis;
- previous treatment with Herceptin for advanced breast cancer;
- concurrent treatment with any other anti-cancer therapy.
Gender: Females
Age limits: Min: 18 Years Max: 75 Years
Accepts healthy volunteers: No
Anticipated start date: December, 2001
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
- Brisbane
- Fitzroy
- Frankston
- Heidelberg
- Hobart
- Malvern
- Melbourne
- Parkville
- Perth
- Sydney
- Waratah
- Wodonga
Belgium
- Brasschaat
- Charleroi
- Namur
Canada
- Edmonton, AB
- North Vancouver, BC
- Brampton, ON
- Newmarket, ON
- Ottawa, ON
- Thunder Bay, ON
- Quebec City, QC
Croatia
France
- Angers
- La Roche Sur Yon
- Lille
- Paris
- Saint Herblain
- Toulon
- Toulouse
Germany
- Berlin
- Frankfurt Am Main
- München
- Rostock
Hungary
Ireland
New Zealand
- Auckland
- Christchurch
- Hamilton
- Palmerston North
- Wellington
Poland
- Gdynia
- Krakow
- Olsztyn
- Warszawa
Romania
- Brasov
- Bucharest
- Cluj-Napoca
- Craiova
- Iasi
- Timisoara
Spain
- Alcoy
- Alicante
- Barcelona
- Elche
- Madrid
- San Juan
- Valencia
Switzerland
United States
- Los Angeles, CA
- San Diego , CA
- Miami, FL
- Tucker, GA
- Chicago, IL
- Southfield, MI
- Great Falls, MT
- New Brunswick, NJ
- Cleveland, OH
- Houston, TX
