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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Breast Cancer
Trial Information
A Study of Herceptin (Trastuzumab) Monotherapy in Women With Metastatic Breast Cancer
Status: Completed
Protocol Number: WO16229
Sponsor: Hoffmann-La Roche AG
Company Division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Herceptin monotherapy on tumor response in women with metastatic breast cancer with HER2 overexpression/amplification
Brief Summary: This study will assess the efficacy of treatment with intravenous Herceptin in patients with metastatic breast cancer who demonstrate overexpression of HER2. The anticipated time on study treatment is until disease progression and the target sample size is <100 individuals.
Target sample size is 80.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Non-Randomized
- Masking: Open Label
- Control: Uncontrolled
- Assignment: Single Group
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Breast Cancer
Intervention Type: Drug
Intervention Name: trastuzumab[Herceptin]
Primary Outcome: 1. Efficacy: Tumor response rate and progression
Key Secondary Outcomes: 1. Efficacy: Time to progression, clinical benefit rate. Safety: Adverse events, LVEF measurement, hematologic and biochemical parameters
Inclusion Criteria:
- female patients >=18 years of age;
- metastatic breast cancer;
- HER2 overexpression.
Exclusion Criteria:
- other invasive malignancy in the past 5 years;
- prior cytotoxic chemotherapy, or >=2 hormone therapies for treatment of metastatic breast cancer.
Gender: Females
Age Limits: Min: 18 Years
Accepts Healthy Volunteers: No
Trial Registration Date: 06/24/2005
Date Last Updated: 12/08/2008
Link To Trial Results
Research Site:
Located In:
Geelong 3220
Australia
Phone: 973-235-5000 or 800-526-6367
View Google Map
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