Trial information
A Study of Avastin (Bevacizumab) plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.
Status: Recruiting
Protocol number: ML21531
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to assess the rate of pathological complete response in patients with primary inflammatory HER2-positive breast cancer treated with Avastin + Herceptin based chemotherapy
Brief summary: This single arm study will assess the efficacy and safety of preoperative treatment with Avastin combined with Herceptin-based chemotherapy in patients with primary inflammatory HER2-positive breast cancer. Patients will be treated with a total of 8 cycles of pre-operative chemotherapy + Avastin + Herceptin. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 50.
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: bevacizumab [Avastin]
Primary outcome: 1. Rate of pathological complete response Time frame: Event driven
Key secondary outcomes: 1. Disease-free survival; recurrence free interval; overall survival. Time frame: Event driven
2. AEs; cardiac safety Time frame: Throughout study
Inclusion criteria:
- adult females, >=18 years of age;
- inflammatory breast cancer;
- HER2-positive tumors;
- performance status 0-2.
Exclusion criteria:
- metastases;
- previous treatment with chemotherapy, radiation therapy or hormone therapy for a breast tumor;
- clinically significant cardiovascular disease, or history of thrombotic disorders.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2008
Trial registration date: 07/15/2008
Date last updated: 12/19/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Ales
- Angers
- Avignon
- Besancon
- Bordeaux
- Brest
- Caen
- Clermont-Ferrand
- Dijon
- Grenoble
- Le Mans
- Lille
- Lyon
- Marseille
- Montpellier
- Mougins
- Nantes
- Nice
- Nimes
- Paris
- Perigueux
- Perpignan
- Reims
- Rennes
- Rouen
- Saint Brieuc
- Saint Herblain
- Saint-Cloud
- Saint-Priest-En-Jarez
- Strasbourg
- Toulouse
- Tours
- Vandoeuvre-Les-Nancy
- Villejuif
