The National Breast Cancer Coalition Fund is partnering with BCIRG (The Breast Cancer International Research Group, a not-for-profit academic, global, cooperative group of oncology researchers) and Aventis Oncology on a phase III clinical trial of a potential new use of the drug Herceptin®. The clinical trial, enrolled 3,150 patients worldwide.

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 was 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 for operable breast cancer with an axillary lymph node dissection or a negative response to sentinel node dissection (T1-3, Clincal NO-1, MO).;
• A mastectomy or lumpectomy must include an axillary node dissection or a negative response to a sentinel node dissection within 60 days of registration;
• Tumor POSITIVE for HER2neu amplification as determined by the FISH test;
• Cancer must be evident either in:
• At least one lymph node (node-positive); or
• No lymph nodes (node-negative) but at least one of the following risk factors exists:
• Tumor size 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 enrolled 3,150 patients worldwide who were randomly assigned to one of the following three treatment regimens: o Adriamycin® (doxorubicin) and Cytoxan® (cyclophosphamide), known as AC and considered to be one of the current standard adjuvant chemotherapy regimens, followed by Taxotere o AC followed by Taxotere with Herceptin® (trastuzumab) or Taxotere, a carboplatin or cisplatin agent (each site's investigator will decide which agent to administer) and Herceptin®. · Patients will complete their chemotherapy treatment in 18 and 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.

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 helped to accrue patients for the trial.