Trial Information

Summary: A Study of Pertuzumab in Combination with Herceptin (Trastuzumab) and Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

Status: Recruiting

Protocol Number: WO20698

Sponsor: Hoffmann-La Roche; Genentech Inc.

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in previously untreated HER2-positive metastatic breast cancer

Brief Summary: This 2 arm study will compare the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in female patients who have HER2-positive metastatic breast cancer and who have not received chemotherapy or biologic therapy for their metastatic disease. Patients will be randomized to one of 2 treatment arms, to receive a) Herceptin + docetaxel + pertuzumab or b) Herceptin + docetaxel + placebo. Herceptin will be administered as a loading dose of 8mg/kg iv then 6mg kg iv 3-weekly, docetaxel at a dose of 75mg/m�² i.v. 3-weekly, and pertuzumab at a loading dose of 840mg iv, then 420mg iv 3-weekly. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is 500+ individuals. Target sample size is 800.

Study Phase: III

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double Blind
  • Control: Active
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Breast Cancer

Intervention Type: Drug

Intervention Name: pertuzumab

Primary Outcome: 1. Progression free survival.

Key Secondary Outcomes: 1. Efficacy: Overall survival, objective response rate. Safety: CHF and asymptomatic LVEF events; LVEF measurements; AEs and lab parameters.

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • cancer of the breast, with locally recurrent or metastatic disease;
  • HER2 positive (FISH-positive or IHC 3+);
  • candidate for chemotherapy;
  • ECOG performance status 0 or 1.

Exclusion Criteria:

  • anticancer therapy for metastatic breast cancer (except for one prior hormonal regimen);
  • tyrosine kinase/HER inhibitors for breast cancer, except Herceptin used in the neoadjuvant or adjuvant setting;
  • systemic breast cancer treatment in neoadjuvant or adjuvant setting, with a disease-free interval from completion of systemic treatment to metastatic diagnosis of <12 months;
  • CNS metastases;
  • clinically relevant cardiovascular disease.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2008

Trial Registration Date: 12/17/2007

Date Last Updated: 10/28/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Baldwin Park, CA 91706
Telephone: 973-235-5000 or 800-526-6367

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: December 2, 2008 at 3:14:51 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA