Trial information
A Study of Pertuzumab in Combination With Herceptin in Patients With Metastatic Breast Cancer.
Status: Recruiting
Protocol number: BO17929
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: An exploratory single-arm study to evaluate the effect of pertuzumab in combination with Herceptin on response rate in patients with HER2-positive metastatic breast cancer
Brief summary: This study will evaluate the efficacy and safety of pertuzumab in combination with Herceptin in patients with metastatic breast cancer who have progressed on Herceptin-based therapy,and will make a preliminary assessment of the efficacy and safety of single agent pertuzumab. Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840mg iv on day 1, followed by 420mg iv every 3 weeks. Herceptin will be administered at the same schedule the patient was following before entry into the study.An additional cohort of patients, at certain centers, will receive pertuzumab monotherapy, at an initial dose of 840mg iv on day 1, followed by 420mg iv every 3 weeks. The anticipated time on study treatment is until disease progression, and the target sample size for all cohorts is <100 individuals. Target sample size is 93.
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: pertuzumab
Primary outcome: 1. Objective response and clinical benefit response according to RECIST
Key secondary outcomes: 1. Efficacy: Time to response; duration of response; time to progression; progression-free survival. Safety: AEs, laboratory abnormalities; LVEF.
Inclusion criteria:
- adult patients, >=18 years of age, with histologically-confirmed HER2-positive breast cancer;
- metastatic breast cancer, with progression on Herceptin-based therapy as last treatment for metastatic disease;
- <=3 chemotherapy regimens prior to study entry;
- last Herceptin dose <=9 weeks before study entry for patients reciving pertuzumab + Herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy;
- LVEF>= 55% at study entry.
Exclusion criteria:
- previous treatment with an anti-cancer vaccine or any targeted therapy other than Herceptin;
- brain metastases;
- history of any cardiac AE related to Herceptin therapy;
- any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2006
Trial registration date: 03/10/2006
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
Canada
- Vancouver, BC
- London, ON
- Ottawa, ON
- Toronto, ON
France
- Besancon
- Dijon
- Lille
- Montpellier
Italy
Spain
United Kingdom
- Edinburgh
- Manchester
- Northwood
- Truro
