Adjuvant Breast Cancer Treatment
Clinical study results
Four pivotal trials involving more than 10,000 women demonstrated that 1 year of Herceptin therapy provided significant clinical benefit.1
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
Select patients for therapy based on an FDA-approved companion diagnostic 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.
Boxed WARNING: Cardiac Monitoring
- Evaluate cardiac function prior to and during treatment. For adjuvant breast cancer therapy, also evaluate cardiac function after completion of Herceptin
- Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan
- Monitor frequently for decreased left ventricular function during and after Herceptin treatment
- Monitor more frequently if Herceptin is withheld for significant left ventricular cardiac dysfunction
Serious adverse events and common side effects of Herceptin in HER2+ early-stage breast cancer.
- Herceptin administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving Herceptin with anthracycline-containing chemotherapy regimens.
- Evaluate left ventricular function in all patients prior to and during treatment with Herceptin. Discontinue Herceptin treatment in patients receiving adjuvant therapy and withhold Herceptin in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity
- Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of Herceptin administration. Interrupt Herceptin infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
- Exposure to Herceptin during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Dosing and administration
Based on the adjuvant breast cancer treatment clinical trials, Herceptin is indicated for 1 full year.1
Boxed WARNING: Infusion Reactions
- Herceptin administration can result in serious and fatal infusion reactions
- Symptoms usually occur during or within 24 hours of Herceptin administration
- Interrupt Herceptin infusion for dyspnea or clinically significant hypotension
- Monitor patients until symptoms completely resolve
- Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly consider permanent discontinuation in all patients with severe infusion reactions
- Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia
- Herceptin Prescribing Information. Genentech, Inc. 2017.