About Herceptin ®

According to the American Cancer Society, breast cancer is the most common cancer among women in the United States, other than skin cancer. For patients with early-stage breast cancer, the standard of treatment has included surgery, chemotherapy, hormonal therapy, and radiation therapy, and targeted therapy.

The aggressive growth of certain breast cancers may be driven by the aberrant activity of growth factor receptors, which are therefore potential targets of therapy with biologic agents that may disrupt signaling. When one such growth-promoting receptor, HER2, is overexpressed, as it is in approximately 25% of breast cancer cases, it is a prognostic factor for reduced patient survival and is associated with enhanced proliferative, invasive, and aggressive tumor behavior.

Herceptin is a monoclonal antibody designed to target HER2 and is indicated in the adjuvant and metastatic setting.

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Indications
Adjuvant indications
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy
Metastatic indications
Herceptin is indicated:
  • In combination with paclitaxel for the first line treatment of HER2 overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2 overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Boxed WARNINGS and Additional Important Safety Information Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction. Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported. Exacerbation of chemotherapy-induced neutropenia has also occurred. The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.

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