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.*
*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.
You must have your cancer tested to determine if your cancer is HER2-positive (or HER2+) before you can start treatment with Herceptin.
†Based upon average weight and vials sold.
‡Herceptin was first FDA approved in 1998 to treat HER2+ metastatic breast cancer. In 2006, the FDA approved Herceptin to treat HER2+ early breast cancer. In 2010, the FDA approved Herceptin to treat HER2+ metastatic stomach cancer.
See some things to keep in mind with Herceptin.
See some things to keep in mind with Herceptin.
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.
Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.
Romond EH, Perez EA, Bryant J, et al; from the National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central Cancer Treatment Group (NCCTG). Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353(16):1673-1684. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052122. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin and cyclophosphamide plus paclitaxel with or without trastuzumab in treating women with node-positive breast cancer that overexpresses HER2. NCT00004067 updated January 15, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00004067. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.
ClinicalTrials.gov. Doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in treating women with HER2-positive node-positive or high-risk node-negative breast cancer. NCT00005970 updated June 4, 2019. At: https://clinicaltrials.gov/ct2/show/record/NCT00005970. Accessed June 24, 2019.
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.
Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al; for the Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353(16):1659-1672. At: https://www.nejm.org/doi/full/10.1056/NEJMoa052306. Accessed June 24, 2019.
Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. At: https://www.nejm.org/doi/full/10.1056/NEJMoa0910383. Accessed June 24, 2019.
Slamon D, Eiermann W, Robert N, et al; for the Breast Cancer International Research Group (BCIRG). Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273-1283. At: https://www.nejm.org/doi/full/10.1056/NEJMoa0910383. Accessed June 24, 2019.
ClinicalTrials.gov. Combination chemotherapy with or without trastuzumab in treating women with breast cancer. NCT00021255 updated November 15, 2016. At: https://clinicaltrials.gov/ct2/show/record/NCT00021255. Accessed June 24, 2019.
ClinicalTrials.gov. Combination chemotherapy with or without trastuzumab in treating women with breast cancer. NCT00021255 updated November 15, 2016. At: https://clinicaltrials.gov/ct2/show/record/NCT00021255. Accessed June 24, 2019.
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