Trial information
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer
Status: No longer recruiting
Protocol number: MO16432
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of paclitaxel, doxorubicin, and CMF neoadjuvant chemotherapy, with and without Herceptin, on tumor response in women with HER2-positive breast cancer
Brief summary: This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negqtive disease will receive the same chemotherapy without Herceptin. The anticipated time on study treatment is 1 year and the target sample size is 100-500 individuals.
Target sample size is
270.
Study phase: II
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. Progression-free survival
Key secondary outcomes: 1. Efficacy: Complete and partial response rates. Safety: Adverse events, laboratory assessments, LVEF
Inclusion criteria:
- female patients, >=18 years of age, with locally advanced breast cancer.
Exclusion criteria:
- previous therapy for any invasive malignancy.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2002
Trial registration date: 06/24/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Austria
Germany
Italy
- Bellunoi
- Bologna
- Carpi
- Castelfranco Veneto
- Milano
- Noale
- Pisa
- San Giovanni Rotondo
- Sassari
- Thiene
- Trento
- Udine
- Vicenza
Portugal
Russian Federation
- Kazan
- Moscow
- St Petersburg
Spain
- Barcelona
- Cádiz
- Madrid
- San Sebastian
- Terrassa
- Valencia
- Zaragoza
