Spotlight

BioOncology Co-Pay Card Program

The BioOncology Co-Pay Card Program gives eligible patients help with their monthly insurance co-payments for Herceptin.

HER Connection Support Line: 866.449.HER2

Have questions about HER2+ breast cancer? Get expert answers from registered oncology nurses at the HER connection Support Line. Call 866.449.HER2 (8AM-8PM ET)

BCIRG 006 Slide Kit

Download: BCIRG 006 Slide Kit (PDF, 5.15MB).

HER connection

Discover HER connection
A program designed to support patients with knowledge and information about HER2+ breast cancer.

BCIRG Study Design

This clinical trail, conducted by the Breast Cancer International Research Group (BCIRG), evaluated the efficacy and cardiac safety of 2 Herceptin-containing regimens vs a control. Patients were randomized (1:1:1) to receive one of the following adjuvant regimens:

  • TCH: Taxotere®* (docetaxel) and carboplatin plus Herceptin
  • AC→TH: doxorubicin and cyclophosphamide followed by Taxotere plus Herceptin
  • AC→T (control): doxorubicin and cyclophosphamide followed by Taxotere

Hormonal therapy and/or radiotherapy were given as appropriate

Click to view the BCIRG Study Design

*Taxotere is a registered trademark of sanofi-aventis U.S. LLC.

close 

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

† 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.

Metastatic indications

Herceptin is indicated:
  • 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

Focus on Her

Based on preclinical studies, Herceptin suppresss HER2 activity by working on both the extracellular and th intracellular domains of the HER2 receptor1-4

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. Sliwkowski MX, Lofgren JA, Lewis GD, Hotaling TE, Fendly BM, Fox JA. Nonclinical studies addressing the mechanism of action of trastuzumab (Herceptin). Semin Oncol. 1999;26(suppl 12):60-70.
  • 2. Yakes FM, Chinratanalab W, Ritter CA, et al. Herceptin-induced inhibition of phosphatidylinositol-3 kinase and AktIs required for antibody-mediated effects on p27, cyclin D1, and antitumor action. Cancer Res.2002; 62(14):4132-4141.
  • 3. Arnould L, Gelly M, Penault-Llorca F, et al. Trastuzumab-based treatment of HER2+ breast cancer: an antibody-dependent cellular cytotoxicity mechanism? Br J Cancer.2006;94(2):259-267.
  • 4. Bianco AR. Targeting c-erbB2 and other receptors of the c-erb B family: rationale and clinical applications. JChemother. 2004; 16 Suppl 4:52-54.


Herceptin® (trastuzumab)Herceptin® (trastuzumab)