Links

This section provides links to relevant Web sites that will help you expand your knowledge about HER2+ breast cancer and gain access to additional information that you may find useful in your practice.

Unless otherwise indicated, Genentech, Inc. is neither affiliated with nor endorses any of the following organizations.

The following lists of associations, societies, and medical databases are not intended to be all-inclusive, but are a representative sampling of information sources:

Associations and Societies

  • American Medical Association (AMA)
  • The nation's leader in promoting professionalism in medicine, setting standards for medical education and ethics, and advancing the betterment of public health.
  • http://www.ama-assn.org/
  • American Society of Clinical Oncology (ASCO)
  • A non-profit organization that supports various types of cancer research, in particular, patient-oriented clinical research.
  • http://www.asco.org
  • National Comprehensive Cancer Network (NCCN)
  • The National Comprehensive Cancer Network (NCCN), an alliance of 19 of the world's leading cancer centers, is an authoritative source of information to help patients and health professionals make informed decisions about cancer care.
  • http://www.nccn.org/
  • Oncology Nursing Society (ONS)
  • A professional organization of more than 30,000 registered nurses and other healthcare providers dedicated to excellence in patient care, education, research and administration in oncology nursing. The overall mission of ONS is to promote excellence in oncology nursing and quality cancer care.
  • http://www.ons.org/
  • San Antonio Breast Cancer Symposium (SABCS)
  • The San Antonio Breast Cancer Symposium (SABCS) is a division of Cancer Therapy & Research Center (CTRC). The CTRC is an independent, non-profit institution directed by a volunteer Board of Governors committed to providing the highest quality cancer treatment, research and education.
  • http://www.ctrc.saci.org/home.cfm

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Medical Databases

  • MEDLINE/PubMed
  • A service of the National Library of Medicine that provides access to over 11 million citations from MEDLINE and additional life science journals, and includes links to additional sites that provide full-text articles and other related resources.
  • http://www.cancer.gov/search/pubmed/
  • National Cancer Institute -CancerLit
  • A bibliographic database, provided as a service of the National Cancer Institute that provides citations and abstracts from medical articles pertaining to a variety of health-related topics.
  • http://www.cancer.gov/search/pubmed/

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Additional Resources

  • ClinicalTrials.gov
  • Provides regularly updated information about federally and privately supported clinical research in human volunteers.
  • http://www.ClinicalTrials.gov
  • Medscape
  • Medscape's mission is to provide clinicians and other healthcare professionals with timely clinical information that is relevant to your patients and practice. After registering for free, Medscape automatically delivers specialty content to you that best fits your profile.
  • http://www.medscape.com
  • National Cancer Institute (NCI)
  • Sponsored by the U.S. government, this organization leads the nation's fight against cancer by supporting cancer research and promoting treatment, prevention and quality of care for patients and their families.
  • http://www.nci.nih.gov
  • Oncolink
  • A professional ogranization that provides information about specific types of cancer, updates on cancer treatments and news about research advances.
  • http://www.oncolink.com

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  • 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

Boxed WARNINGS and Additional Important Safety Information

  • Cardiotoxicity
  • 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 for breast cancer and strongly consider discontinuation of Herceptin in patients with metastatic breast cancer who develop a clinically significant decrease in left ventricular function.
  • Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death.
    • In one adjuvant clinical trial, cardiac ischemia or infarction occurred in the Herceptin-containing regimens.
    • Herceptin can also cause asymptomatic decline in LVEF.
  • Cardiac Monitoring
  • Candidates for treatment with Herceptin should undergo a thorough baseline cardiac assessment, including history, physical examination, and an assessment of LVEF by echocardiogram or MUGA scan.
    • Patients should undergo frequent monitoring for decreased left ventricular function during and after Herceptin treatment.
    • More frequent monitoring should be employed if Herceptin is withheld in patients who develop significant left ventricular cardiac dysfunction.
  • Infusion reactions and Pulmonary Toxicity
  • 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
  • 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.
    • In postmarketing reports, serious and fatal infusion reactions have been reported. Discontinue Herceptin in all patients with severe or life-threatening infusion reactions.
  • Herceptin use can result in serious and fatal pulmonary toxicity, which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis.
    • Such events can occur as sequelae of infusion reactions.
    • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
  • Neutropenia
  • Exacerbation of chemotherapy-induced neutropenia has also occurred
    • In controlled clinical trials, severe neutropenia and febrile neutropenia occurred more frequently in metastatic breast cancer patients receiving Herceptin with myelosuppressive chemotherapy compared to chemotherapy alone.
    • The incidence of septic death was not significantly increased.
  • Pregnancy Category D
  • Herceptin can cause fetal harm when administered to a pregnant woman.
  • Post-marketing reports suggest that Herceptin use during pregnancy increases the risk of oligohydramnios during the second and third trimester.
  • 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.



Herceptin® (trastuzumab)Herceptin® (trastuzumab)