Spotlight

December 10–14, 2008 at the Henry B. Gonzalez Convention Center. Learn more about this event.

Meet nominated nurses who have demonstrated exceptional commitment to caring for their patients.

Meet some of the women who have battled HER2+ breast cancer in the Herceptin era. We hope that you will find inspiration in their strength and passion for life.

Download: BCIRG 006 Slide Kit (PPT, 7.7MB).

Review the proposed Herceptin Mechanism of Action.

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

• In combination with paclitaxel for 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

• Adjuvant Treatment Quick Links

• Metastatic Treatment Quick Links

• For Nurses

• • Pivotal Studies and Efficacy
  • Treatment Duration
  • Cardiac Safety Profile
  • BCIRG 006 Clinical Overview (PDF) 390KB
• • Pivotal Studies and Efficacy
  • Dosing and Administration
  • Proposed Mechanisms of Action
• • For Nurses Home
  • Links for Nurses
  • Nurse Patient Materials
  • Download Checklist for Nurses (PDF) 148KB

Boxed WARNINGS and Additional Important Safety Information

• Cardiotoxicity and Cardiac Monitoring
• Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure (CHF) and decreased left ventricular ejection fraction (LVEF).
  • The incidence and severity of left ventricular cardiac dysfunction was highest in patients who received Herceptin concurrently with anthracycline-containing chemotherapy regimens.
  • Discontinue Herceptin treatment in patients receiving adjuvant therapy and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.
• Patients should undergo monitoring for decreased left ventricular function before Herceptin treatment, and frequently during and after Herceptin treatment.
  • More frequent monitoring should be employed if Herceptin is withheld in patients who develop significant left ventricular cardiac dysfunction.
• In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.

• Infusion Reactions, Pulmonary Toxicity and Neutropenia
• Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported.
  • In most cases, symptoms occurred during or within 24 hours of administration of Herceptin. Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension.
  • Patients should be monitored until signs and symptoms completely resolve.
  • Discontinue Herceptin for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.
• Exacerbation of chemotherapy-induced neutropenia has also occurred.

Pregnancy Category D

Herceptin can cause oligohydramnios and fetal harm when administered to a pregnant woman.

Most Common Adverse Events

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.

Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.

• References:
• 1. Data on file. Genentech, Inc.
• 2. Herceptin® (trastuzumab) Full Prescribing Information, Genentech, Inc. May 2008.