Description Herceptin® (Trastuzumab) is a humanized antibody designed to target and block the function of HER2 protein overexpressing cells. It inhibits cancer cell division and growth by seeking out extra HER2 protein receptors on the surface of cancer cells, attaching itself to these areas and preventing the HER2 growth response.

Development Status Phase III clinical trials are ongoing evaluating Herceptin in combination with Avastin for HER2-positive first-line metastatic breast cancer and for adjuvant HER2-positive breast cancer; evaluating Herceptin plus chemotherapy in combination with pertuzumab for HER2-positive first-line metastatic breast cancer; and evaluating two years of Herceptin administration for adjuvant HER2-positive breast cancer (HERA 2-year).

Herceptin is being developed in collaboration with F. Hoffmann-La Roche.

Approved Uses

• In September 1998, the U.S. Food and Drug Administration (FDA) approved Herceptin for use in patients with metastatic breast cancer whose tumors overexpress the HER2 protein. It is indicated for treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy.
• In November 2006, the FDA approved Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment of patients with HER2-overexpressing, node-positive breast cancer.
• In January 2008, the FDA approved Herceptin as a single agent for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multi-modality anthracycline-based therapy.
• In May 2008, the FDA approved Herceptin for adjuvant treatment of patients with HER2-overexpressing, node-positive and high-risk node-negative breast cancer as part of:
  • a non-anthracycline treatment regimen containing docetaxel and carboplatin, and
  • with docetaxel following an anthracycline treatment regimen containing doxorubicin and cyclophosphamide.

Read more about Herceptin's approved uses.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

July 2008