Ask the Experts

1. What is HER2?
2. Why and how does HER2+ breast cancer develop?
3. How is HER2 breast cancer different?
4. How is HER2+ breast cancer diagnosed?
5. How is metastatic breast cancer treated?
6. What are targeted therapies and how do they work?
7. What is TYKERB?
8. How is TYKERB different?
9. What are some of the potential side effects of TYKERB?
10. What were the results of the pivotal clinical trial of TYKERB?
11. When should treatment with TYKERB be considered?

1. What is HER2?

HER2 is the human epidermal growth factor receptor 2. It is a gene that makes a protein that's present to some degree in normal cells. But, HER2 is present in much larger amounts in cancers, particularly breast cancer. About 25 percent to 30 percent of breast cancer patients have too much HER2, and these types of breast cancers are referred to as HER2 positive (HER2+).⁴

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2. Why and how does HER2+ breast cancer develop?

HER2 is a gene that's present in normal cells, generally two copies per cell. If a cancer cell has more than two copies, we refer to it as HER2+, or HER2 positive. Cells that have more HER2 lead to abnormal cell growth. They don't have the brakes normal cells do, which tell them when to stop growing or when to stop dividing. Too much HER2 tells the cell to keep growing and dividing. And this abnormal cell growth leads to the development of tumors, particularly in the breast.⁴

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3. How is HER2 breast cancer different?

HER2+ breast cancer is a type of cancer that tends to be more aggressive. It's more aggressive due to the presence of more HER2 than should normally be in breast cells. More HER2 allows cells to grow and divide more rapidly than cells with less HER2.^18,19

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4. How is HER2+ breast cancer diagnosed?

HER2+ breast cancer is diagnosed by looking at the cancer cells [under a microscope] once the tumor is removed. Generally, a pathologist does this test. And, it can be evaluated in one of two different ways. One way is a particularly sophisticated test on tumor tissue called FISH [to measure the number of HER2 genes inside a cell]. The other test stains the tumor for the presence of HER2's proteins. These tests determine whether or not a cancer is HER2+.^19,20

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5. How is metastatic breast cancer treated?

A number of different modalities or treatment approaches are available for patients with advanced disease. How we use them, in what sequence, and what preference we use them is based not only on the patient, but the characteristics of the disease.²¹

Metastatic breast cancer is cancer that has gone beyond the area where it started and has spread through the bloodstream or some other way to distant parts in the body. Using the example of breast cancer—it has gone beyond the breast. And, it may be present in the bone, or the liver, the lung or brain. Another general term is advanced disease. How we treat that disease is based on features of the cancer cell itself.²²

If we're evaluating a woman with a new diagnosis of metastatic breast cancer, we first determine whether or not the tumor has hormone receptors. If they are present, it tells us that this is a patient who might benefit from treatments that interfere with the effects of hormones, called anti-hormone therapy.²⁷

Another example is targeting HER2. For the 25 to 30 percent of patients with breast cancer that is HER2 positive, we now have drugs available to target that particular feature. By doing so, these therapies slow down the growth of HER2+ tumor cells.⁴

Chemotherapy is another example of a treatment we use in many patients with breast cancer. Chemotherapy is a targeted therapy in a crude sense, because it interferes with how cancer cells grow. But, chemotherapy also affects normal, healthy cells as well. This causes the side effects that patients may experience—things such as hair loss, nausea or decreasing blood counts.^9,29

Radiation therapy is a type of therapy we typically think of as used for patients with early stage disease. But in reality, patients with metastatic disease may be recommended radiation therapy as well to help with symptoms such as pain. For example, patients who have cancer in their bone that is painful may receive radiation therapy to that particular area, the goal being to eradicate the pain. Another example might be radiation therapy for patients with brain metastases where cancer cells have spread to the brain. In these examples, the goal of radiation therapy is not necessarily to cure the disease, but rather to address an area that's very problematic in that particular patient.¹⁹

We also use therapies in combination. There are plenty of examples where we use chemotherapy with other drugs when we know that combining treatments may be beneficial. ¹⁹

A number of different treatment approaches are available for patients with advanced disease. How we use them, in what sequence, and what preference we use them is based not only on the patient, but the characteristics of the disease.

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

Targeted therapies identify and target a unique feature on a cancer cell that's different than other normal, healthy cells. An example might be patients who have hormone receptor positive breast cancer. These cancers may be growing as a result of hormones that normally circulate in a woman's body, such as estrogen. A targeted therapy for hormone receptor positive breast cancer would be anti-hormone therapy. Anti-hormone therapies try to get rid of hormones that are normally present or to interfere with their effect on a tumor cell.^2,27

Another example would be the 25 to 30 percent of patients with breast cancers that overexpress HER2. HER2 is a protein that is normally expressed, or present, to some degree in cells. But when overexpressed, HER2 can lead cells to develop into tumors quickly and aggressively. We now have drugs that, when combined with chemotherapy, can target HER2+ breast cancer. And, by using targeted therapies for HER2, we're able to significantly improve the outcome of patients with HER2+ metastatic disease.^1,4,18

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7. What is TYKERB?

TYKERB is an oral medication–it's actually a tablet–that's given to patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have had prior treatment with an anthracycline, a taxane, and Herceptin. ¹

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8. How is TYKERB different?

TYKERB is an oral medication. It is a targeted therapy for patients with HER2+ metastatic breast cancer. TYKERB works on the inside of the cancer cell, disrupting how cancer cells grow, divide and multiply.¹

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9. What are some of the potential side effects of TYKERB?

Serious side effects of TYKERB include heart problems, liver problems, lung problems and severe diarrhea. Call your doctor right away if you have palpitations, persistent cough, shortness of breath, or severe diarrhea.

The two most common side effects of TYKERB are diarrhea and rash. It can also cause nausea and vomiting in some patients. And, some patients will complain of fatigue. In most cases, these side effects were mild to moderate in degree.

Another side effect that may occur with TYKERB plus Xeloda is what’s referred to as hand-foot syndrome. This is redness of the hands and soles of the feet and a numbness or funny sensations (paresthesias) in the hands and feet.

These are not all of the possible side effects of TYKERB. Any symptoms that a patient experiences related to treatment for cancer should be brought to the attention of her physician.¹ TYKERB plus Xeloda may also cause a dry cough or shortness of breath, which may be signs of inflammation in the lungs.

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10. What were the results of the pivotal clinical trial of TYKERB?

The pivotal trial comparing Xeloda alone to TYKERB plus Xeloda demonstrated that the growth of breast cancer was delayed significantly in those patients receiving the combination compared to those taking Xeloda alone. Based on these results, it was demonstrated that the combination of TYKERB plus Xeloda was superior to Xeloda alone.¹

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11. When should treatment with TYKERB be considered?

Only your doctor can decide when TYKERB should be considered. TYKERB, in combination with Xeloda, is FDA-approved 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).

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Check out GlaxoSmithKline's Tykerb^® CARES support program to help patients and the healthcare providers who treat them.

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