Spotlight
Download: BCIRG 006 Clinical Overview (PDF, 390KB).
View study design.
Review the proposed Herceptin Mechanism of Action.
BCIRG Study Design
BCIRG 006 included more than 3,200 patients and examined the safety and efficacy of two adjuvant Herceptin-containing regimens in patients with HER2+ breast cancer. 2 Patients were required to have either node-positive disease, or node-negative disease with at least one of the following high-risk features: ER/PR-negative, tumor size > 2 cm, age < 35 years, or histologic and/or nuclear grade 2/3. Patients were randomized (1:1:1) to receive one of the following adjuvant regimens: 2
- AC-->T (control): doxorubicin and cyclophosphamide followed by docetaxel
- AC-->TH: doxorubicin and cyclophosphamide followed by docetaxel plus Herceptin
- TCH: docetaxel and carboplatin plus Herceptin
Health Care Provider Letter
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
Adjuvant Treatment Quick Links
Metastatic Treatment Quick Links
For Nurses
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.
