Herceptin is approved for the treatment of early breast cancer (EBC) that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes. In the case of HER2+ EBC that has not spread to the lymph nodes, it must meet the following condition: the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin is also approved for the treatment of HER2+ breast cancer that has spread to other parts of the body (metastatic breast cancer).
Patients are selected for therapy based on an FDA-approved test for Herceptin.
*High risk is defined as ER/PR-positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.
It’s a type of protein found in everyone. HER2 receptors are on the surface of both normal cells and cancer cells.
This protein tells cells to grow and divide. Too much HER2 is called "HER2 overexpression" or "HER2+."
In breast cancer that is HER2+, the cancer cells have too many HER2 receptors.
If you receive Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk), an injection given under the skin (subcutaneous) instead of IV (intravenous), here’s some information to keep in mind.
If you receive Herceptin in combination with another HER2-targeted treatment + chemotherapy, here’s some information to keep in mind.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
Herceptin Prescribing Information. Genentech, Inc. February 2021.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
FDA Approval Letter. Herceptin. September 25, 1998. At: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Jackisch C. HER-2-positive metastatic breast cancer: optimizing trastuzumab-based therapy. Oncologist. 2006;11(suppl 1):34-41. At: http://theoncologist.alphamedpress.org/content/11/suppl_1/34.full.pdf+html. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792. At: https://www.nejm.org/doi/full/10.1056/NEJM200103153441101. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
Marty M, Cognetti F, Maraninchi D, et al; for the M77001 Study Group. Randomized Phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: the M77001 Study Group. J Clin Oncol. 2005;23(19):4265-4274. At: https://ascopubs.org/doi/pdf/10.1200/JCO.2005.04.173. Accessed June 24, 2019.
The BrandX™ Co-pay Card Program may help lower the out-of-pocket costs for your patients.
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