Trial information
A Study of Pertuzumab in Patients With Metastatic Breast Cancer
Status: Completed
Protocol number: BO16934
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of different doses of pertuzumab on treatment response in patients with metastatic breast cancer with low HER2 expression
Brief summary: This study will assess the efficacy and safety of 2 different doses of pertuzumab in patients with previously treated HER2 negative metastatic breast cancer. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Target sample size is 120.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: pertuzumab
Primary outcome: 1. Efficacy: Objective response rate
Key secondary outcomes: 1. Time to response, objective stable disease, duration of overall and complete response, time to progression and to treatment failure, survival
Safety: AEs, changes in serum and plasma markers of cardiac damage, ECHO measurements
Inclusion criteria:
- histologically-confirmed HER2 negative metastatic breast cancer;
- disease progression on or after <=2 different chemotherapy regimens, including an anthracycline-containing therapy.
Exclusion criteria:
- central nervous system metastases;
- previous chemotherapy, radiotherapy, or immunotherapy within 4 weeks of study or hormone therapy within 2 weeks of study;
- previous treatment with any drug that targets the HER2 receptor family;
- previous treatment with corticosteroids as cancer therapy.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 07/26/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Belgium
Finland
Germany
Italy
Netherlands
Spain
United Kingdom
- Edinburgh
- London
- Manchester
