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Ask the Experts


Tona M. Gilmer, PhD, Research Scientist

Dr. Tona Gilmer is director of Oncology Translational Research for GlaxoSmithKline. Her department was responsible for the initial biological development and testing of TYKERB. In this interview, she answers some common questions patients and caregivers have about clinical trials, HER2, targeted therapies and TYKERB.

  1. What are clinical trials and how do they work?
  2. What is HER2?
  3. What are targeted therapies and how do they work?
  4. What is TYKERB?
  5. How does TYKERB work?
  6. How is TYKERB different?
  7. What results has TYKERB shown with Xeloda in clinical trials?

1. What are clinical trials and how do they work?

Clinical trials are very important steps when creating a new drug. Clinical trials are composed of mainly three different stages: Phase 1 clinical trials normally test the safety of a drug. It's the first time that a drug would be tested in humans. We also hope that the Phase 1 clinical trials show whether the drug is going to have some initial benefits for the patients in the trial. Phase 2 clinical trials test whether the drug works (efficacy) in a special group of patients, as well as safety. For example, it would be tested in breast cancer patients who are HER2-positive (HER2+). Phase 3 clinical trials compare the new drug with the best standard of care. One group would receive the best available treatment for that particular cancer. Another group of patients may receive that same effective treatment, but also receive the test drug to learn whether or not the new drug has additional benefits.

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2. What is HER2?

HER2 is human epidermal growth factor receptor 2. It's a very important protein involved in both healthy cell and tumor cell growth and reproduction. It's a gene that produces the HER2 protein. Normal cells contain two copies of the HER2 gene. However, if a cell contains multiple copies of the HER2 gene, it is considered HER2-positive, or HER2+.4

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3. What are targeted therapies and how do they work?

A targeted therapy is one that attacks or focuses on a target in a cancer cell. We can think of the targeted therapy as being able to attack the tumor cell, while minimizing damage to normal cells. The other important thing about a targeted therapy is that it can attack the tumor cell from outside the cell. Or, it can enter into the tumor cell and attack it from inside. Both of these types of processes are important and can have an effect on the growth of a cancer cell.2

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4. What is TYKERB?

TYKERB is an oral medication, a tablet that is used with Xeloda to treat patients with advanced or metastatic breast cancer who are HER2+ who have previously received specific types of therapy, including an anthracycline, a taxane, and Herceptin, before being given this particular combination. TYKERB also works inside the cell to block the specific targets that are responsible for the cell growth and proliferation of HER2+ breast cancer.1

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5. How does TYKERB work?

TYKERB works by entering the cancer cell and stopping the activity of excess HER2 proteins. It binds to a site on the HER2 protein inside the cell. Stopping that activity may inhibit or block the tumor cell from growing or may slow down its growth. TYKERB enters the cell and inhibits, attacks, and blocks the activity of the excess HER2 proteins that are part of tumor cell growth.1

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6. How is TYKERB different?

TYKERB is a small molecule. It's an oral medication, a tablet that works inside the cell. It works inside the cell to block the activity of the HER2 molecule, as opposed to outside the cell.1

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7. What results has TYKERB shown with Xeloda in clinical trials?

The data from the large clinical trial that was testing TYKERB in combination with Xeloda versus Xeloda alone showed that the patients who received the combination had more time before their cancer progressed than patients who received Xeloda alone.1

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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.