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About breast cancer

Normally, cells undergo a steady process of growth, dividing when necessary to produce new cells. As cells age, they die, and new cells take their place. Cancer cells don't follow this normal process. Cancer cells reproduce and grow out of control. They also live longer than normal cells.23 Breast cancer is the development of these abnormal cells in the breast.24

What causes breast cancer is not well understood. It is likely a combination of factors (many still unknown) that make cells in the breast turn cancerous.25 There are also many different factors that can affect how quickly the cancer grows and spreads. These factors also affect which treatments may be effective. One of these factors is whether or not a tumor is HER2+ (or HER2-positive).4

HER2 (human epidermal growth factor receptor 2) is a protein that plays an important role in how cells grow, multiply, and survive. Normal cells contain two copies of the HER2 gene, and produce enough HER2 for normal cell growth and division. Some cancer cells contain more than two copies of the HER2 gene. Breast cancers with too many of these types of cells are called HER2+. About 20% to 25% of breast cancer tumors are HER2+.4

Breast cancer cells that are HER2+ grow and reproduce faster than other cancer cells. HER2+ cancer also does not respond to treatment with some drugs.4 HER2 testing is important to find out if certain targeted treatments should be used.

Cancer staging

Cancer is staged according to the size of tumors, how much they have spread, and whether or not lymph nodes are involved.26

  • Stage I: The tumor measures up to two centimeters, and no lymph nodes are involved
  • Stage II: The tumor measures from two to five centimeters, or the cancer has spread to the lymph nodes under the arm on the same side as the breast cancer
  • Stage IIIA: The tumor is larger than five centimeters or has spread significantly to the lymph nodes
  • Stage IIIB: The tumor may be any size, but has spread to the breast skin, chest wall, or internal mammary lymph nodes
  • Stage IV (metastatic): The tumor has spread beyond the breast, underarm, and internal mammary glands to the lungs, liver, bones, or brain26

Learn more about metastatic (or advanced) breast cancer.



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Indication

TYKERB is indicated in combination with Xeloda® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin® (trastuzumab).

Important Safety Information

Some women may develop liver damage while taking TYKERB. The cause of this damage is not known. In some cases, liver damage may be severe and may cause death. Your doctor should test your liver before and during treatment with TYKERB to check for signs of liver damage. You should contact your doctor if you have itching, yellow eyes or skin, dark urine, pain in your right upper side of your belly or feel very tired. If you develop liver damage during your treatment, your doctor may tell you to stop taking TYKERB. Before taking TYKERB, tell your doctor if you have liver problems. You may need a lower dose of TYKERB.

Before taking TYKERB, tell your doctor if you have heart problems. As with other treatments for HER2-positive advanced or metastatic breast cancer, there have been reports of changes in how the heart pumps blood through the body and how the heart beats. Call your doctor right away if you are short of breath, have rapid heartbeats (palpitations), or feel very tired.

Some people taking TYKERB have reported diarrhea. In some cases, diarrhea can be severe. Call your doctor right away if you have diarrhea. It is important to manage diarrhea with medicine as soon as it begins. Severe diarrhea may need to be treated with electrolytes and fluids given by mouth or by vein. Treatment with TYKERB may have to be delayed for a while or stopped completely.

If you have a dry cough or have shortness of breath, talk with your doctor. These may be signs of inflammation in the lungs.

Women should not become pregnant when taking TYKERB because the unborn baby may be harmed.

The most common side effects reported by patients taking TYKERB and Xeloda were diarrhea; vomiting; feeling sick to your stomach (nausea); feeling tired; red, painful hands and feet; and rash.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines and herbal and dietary supplements.

Because TYKERB is currently indicated to be taken with another medicine called Xeloda, be sure to talk with your doctor about any medicines and supplements that should be avoided when taking Xeloda.

Please see complete US Prescribing Information for TYKERB.

Herceptin is a registered trademark of Genentech, Inc.
Xeloda is a registered trademark of Roche Laboratories Inc.

Photos are for illustrative purposes only.