Herceptin Phase III Breast Cancer Clinical Trial


		HERCEPTIN TRIAL Breast Cancer International Research Group Adjuvant Herceptin^® Phase III Breast Cancer Clinical Trial Now Enrolling Introduction The National Breast Cancer Coalition Fund is partnering with BCIRG (The Breast Cancer International Research Group, a not-for-profit academic, global, cooperative intergroup of oncology researchers) and Aventis Oncology, the pharmaceutical sponsor, on a phase III clinical trial of a potential new use of the drug Herceptin^®. The Clinical trial, which will enroll 3,150 patients worldwide, is now open. What is Herceptin^®? Herceptin^® is a drug that is used to treat women with advanced breast cancer who test positive for HER2-neu amplification. The HER2-neu gene is normally involved in regulating cell growth and cell death. Amplification of the HER2-neu gene is linked to rapid cancer growth and decreased patient survival, and is found in approximately 20—25 percent of malignant breast tumors. A recent study published in the New England Journal of Medicine found that Herceptin^® extended survival for women with advanced breast cancer by 24 percent when added to chemotherapy drugs. Researchers hope Herceptin^® will work even better in patients with newly diagnosed breast cancer. Who is Eligible for the Phase III Trial? A woman must have all of the following to be eligible: A mastectomy with axillary lymph node dissection or breast conserving surgery with lymph node dissection for operable breast cancer (T1-3, Clinical N0-1, M0); A mastectomy or lumpectomy must include axillary node dissection within 60 days of registration; Tumor POSITIVE for HER2-neu amplification as determined by the FISH test; Cancer must be evident either in: At least on lymph node (node-positive); or No lymph nodes (node-negative) but at least one of the following risk factors exists: Tumor size no more than two centimeters; Estrogen receptor and progesterone receptor status negative; Histological and/or nuclear grade 2-3; and/or Younger than 35 years of age. Age 18–70 years; Normal bone marrow, liver, renal and cardiac function; No prior systemic therapy or radiation therapy for breast cancer; Willing to provide informed consent; Willing to provide tumor sample for testing of FISH and other markers. How is the Study Designed? The BCIRG-006 study will enroll 3,150 patients worldwide who will be randomly assigned to one of the following three treatment regimens: Adriamycin^® (doxorubicin) and Cytoxan^® (cyclophosphamide), known as AC and considered to be one of the current standard adjuvant chemotherapy regimens, followed by Taxotere; AC followed by Taxotere with Herceptin^® (trastuzumab); or Taxotere, carboplatin or cisplatin agent (each site’s investigator will decide which agent to administer) and Herceptin^®. Patients will complete their chemotherapy treatment in 18 to 24 weeks depending on the regimen assigned. In addition, those receiving the Herceptin^® treatment will begin that treatment on Day 1 of the chemotherapy and continue treatment for one full year. The primary endpoint is Disease Free Survival. The secondary endpoint is: Overall survival; Toxicity and quality of life; Cardiac toxicity; and To evaluate pathologic and molecular markers for predicting efficacy. There are approximately 127 clinical trial sites in the United States. How has NBCCF been involved? NBCCF has been involved in many aspects of the design and implementation of this Herceptin^® adjuvant trial. Representatives of NBCCF have served on the Steering Committee; attended and participated in the investigator meetings; served on the data and safety monitoring committee and now are helping to accrue patients for the trial. For more information contact: National Breast Cancer Coalition Fund 1707 L Street, NW Suite 1060 Washington, D.C. 20036 202-296-7477 voice 202-265-6854 fax www.stopbreastcancer.org (link opens in new window) Article reprinted with permission of National Breast Cancer Coalition Fund.

		Last Update: 10-Mar-2007
		About Us Programs Legislation News BC Emergency Fund Donate Now Calendar Membership Events License Plate Resources Support Our Work Get in Touch Home © 2000—2007 Connecticut Breast Cancer Coalition/Foundation. All rights reserved. Disclaimer

HERCEPTIN TRIAL