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Therapeutic Areas: Oncology | Obstetrics/Gynecology
Disease Category: Breast Cancer
Trial Information
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Status: Recruiting
Protocol Number: WO20697
Sponsor: Hoffmann-La Roche
Company Division: Pharmaceutical
Official Scientific Title: A randomized, open label study to compare the complete pathological response rate achieved with Herceptin plus docetaxel, versus Herceptin plus docetaxel plus pertuzumab, versus Herceptin plus pertuzumab, versus pertuzumab and docetaxel in patients with locally advanced, inflammatory or early stage
Brief Summary: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 400.
Study Phase: II
Study Design / Study Details:
- Purpose: Treatment
- Allocation: Randomized
- Masking: Open Label
- Control: Active
- Assignment: Parallel
- Endpoints: Safety/Efficacy
Study Type:
Interventional
Condition: Breast Cancer
Intervention Type: Drug
Intervention Name: pertuzumab
Primary Outcome: 1. Pathological complete response rate Time frame: Post-surgery
Key Secondary Outcomes: 1. Disease-free interval, PFS, breast-conserving surgery rate. Time frame: Event driven
2. AEs, laboratory parameters, LVEF Time frame: Throughout study
Inclusion Criteria:
- female patients, >=18 years of age;
- locally advanced, inflammatory or early stage invasive breast cancer;
- HER2 positive (HER2+++ by IHC or FISH/CISH+).
Exclusion Criteria:
- metastatic disease (Stage IV) or bilateral breast cancer;
- previous anticancer therapy or radiotherapy for any malignancy;
- other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
- insulin-dependent diabetes;
- clinically relevant cardiovascular disease.
Gender: Females
Age Limits: Min: 18 Years
Accepts Healthy Volunteers: No
Anticipated Start Date: December, 2007
Trial Registration Date: 10/15/2007
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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