Related pages Drug Information Summaries 1 Approval Process for New Cancer Treatments 2 Access to Investigational Drugs: Q & A 3

This page contains brief information about trastuzumab and a collection of links to more information about the use of this drug, related news and research results, and ongoing clinical trials.

US Brand Name(s):		Herceptin
FDA Approved:		Yes

Trastuzumab is approved by the Food and Drug Administration (FDA) to treat breast cancer that is HER2 positive and has metastasized (spread to other areas of the body) after treatment with other anticancer drugs. Trastuzumab is also approved to be used with other drugs to treat HER2-positive breast cancer that has spread to the lymph nodes. It is used after surgery.

Trastuzumab is also being studied in the treatment of other types of cancer.

FDA Approval for Trastuzumab ⁴ - Information from the FDA about the approval of this drug and the clinical trials that led to the approval.

Definition from the NCI Drug Dictionary ⁵ - Detailed scientific definition and other names for this drug.

The ALTTO (Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Breast Cancer Trial (03/12/2008) ⁶ - Information about a major NCI-supported clinical trial for this drug.

Clinical Trial Results: Heart Problems From Trastuzumab Do Not Increase in the Short Term (06/25/2007) ⁷ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: New Trastuzumab Regimen Lessens Cardiac Side Effects (03/01/2006) ⁸ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Trastuzumab Effective in Early Breast Cancer (10/24/2005) ⁹ - Important clinical trial results for this drug, background information, and how the trial was done.

Clinical Trial Results: Dose-Dense Chemotherapy Helped Patients with Metastatic Breast Cancer (06/05/2004) ¹⁰ - Important clinical trial results for this drug, background information, and how the trial was done.

Trastuzumab Combined with Chemotherapy Improves Disease-Free Survival for Patients with Early-Stage Breast Cancer (04/25/2005) ¹¹ - Information from the NCI Press Office about this drug.

Herceptin: Questions and Answers (06/13/2006) ¹² - Information about the use of this drug to treat cancer.

MedlinePlus Information on Trastuzumab ¹³ - A lay language summary of important information about this drug that may include the following:

• warnings about this drug,
• what this drug is used for and how it is used,
• what you should tell your doctor before using this drug,
• what you should know about this drug before using it,
• other drugs that may interact with this drug, and
• possible side effects.

Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. This NLM patient information sheet applies only to approved uses of the drug. However, much of the information may also apply to unapproved uses that are being studied.

Clinical Trials for Trastuzumab ¹⁴ - Check for trials from NCI's PDQ Cancer Clinical Trials Registry now accepting patients.

Glossary Terms

Cancer that forms in tissues of the breast, usually the ducts (tubes that carry milk to the nipple) and lobules (glands that make milk). It occurs in both men and women, although male breast cancer is rare.

A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord.

Any substance, other than food, that is used to prevent, diagnose, treat or relieve symptoms of a disease or abnormal condition. Also refers to a substance that alters mood or body function, or that can be habit-forming or addictive, especially a narcotic.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The Food and Drug Administration also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called FDA.

A protein involved in normal cell growth. It is found on some types of cancer cells, including breast and ovarian. Cancer cells removed from the body may be tested for the presence of HER2/neu to help decide the best type of treatment. HER2/neu is a type of receptor tyrosine kinase. Also called c-erbB-2, human EGF receptor 2, and human epidermal growth factor receptor 2.

A rounded mass of lymphatic tissue that is surrounded by a capsule of connective tissue. Lymph nodes filter lymph (lymphatic fluid), and they store lymphocytes (white blood cells). They are located along lymphatic vessels. Also called lymph gland.

To spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor are like those in the original (primary) tumor.

A test result that reveals the presence of a specific disease or condition for which the test is being done.

A procedure to remove or repair a part of the body or to find out whether disease is present. An operation.