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At a Glance
Why Get Tested?
To determine whether a breast cancer tumor is positive for Her-2/neu, which helps to guide treatment and determine prognosis
When To Get Tested?
When you have been diagnosed with invasive breast cancer and your doctor wants to determine whether the Her-2/neu gene is being over-expressed in the tumor
Sample Required?
A sample of breast cancer tissue obtained during a biopsy or a tumor removed surgically during a lumpectomy or mastectomy; sometimes a blood sample drawn from a vein in your arm
Test Preparation Needed?
What is being tested?
Her-2/neu is an oncogene. It is a gene that codes for a protein that is a receptor for a particular growth factor that promotes cell growth. Normal epithelial cells found throughout the body contain two copies of the Her-2/neu gene and produce low levels of the Her-2/neu protein on the surface of their cells. In about 20-30% of invasive breast cancers (and some other cancers, such as ovarian and bladder cancer), the Her-2/neu gene is amplified and its protein is over-expressed. Tumors that have this over-expression tend to grow more aggressively and resist endocrine (anti-hormone) therapy and some chemotherapies. People with Her-2/neu positive breast cancers tend to have a poorer prognosis, but this tumor characteristic also makes them candidates to receive treatment specific for Her-2/neu-positive cancers.

To determine if a tumor is positive for Her-2/neu, a biopsy is taken and the sample of tumor is tested. There are two main ways to test Her-2/neu status: immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH). IHC measures the amount of Her-2/neu protein present. FISH looks at the genetic level for actual gene amplification – the number of copies of the gene present. IHC is currently the most widely used initial testing method; however, if it is indeterminate or negative, then the FISH method is often done as a follow-up test.

A Her2/neu test blood test is also available. The amount of Her-2/neu protein present in the serum is loosely associated with the amount of Her-2/neu -positive cancer present. This test is not used for screening purposes and is not a substitute for tissue testing but may be ordered to help assess a person's prognosis and to monitor the effectiveness of treatment. After an initial diagnosis of metastatic breast cancer is made, this blood test may be performed and, if the initial level is greater than 15 ng/mL, then the test may be used to monitor treatment.

How is the sample collected for testing?

A sample of breast cancer tissue is obtained by doing a fine needle aspiration, needle biopsy, or surgical biopsy. For the Her-2/neu blood test, a blood sample is drawn from a vein in the arm.

Is any test preparation needed to ensure the quality of the sample?

No test preparation is needed.
Accordion Title
Common Questions
  • How is it used?

    After a diagnosis of metastatic breast cancer has been made, Her-2/neu testing may be used as a prognostic marker to help determine how aggressive the breast cancer tumor is likely to be. It is usually ordered along with estrogen and progesterone hormone receptor status tests (ER and PR). The results of these three tests give the doctor information about the person's likely prognosis and response to specific therapies such as hormone therapy and chemotherapy.

    The serum Her2/neu test is sometimes used to monitor Her2/neu-positive breast cancer patients who are receiving cancer therapy including, for example, hormone therapy, chemotherapy, or Her-2/neu targeted therapy. If the level of serum Her-2/neu is initially elevated (greater than 15 ng/mL) then falls, it is likely that treatment is working; if it stays elevated, treatment is not working; and if the level falls then rises, the cancer may be recurring.

  • When is it ordered?

    Her-2/neu tissue testing is recommended along with estrogen and progesterone receptor status testing as part of an initial workup of invasive breast cancer and is sometimes performed with recurrent breast cancer. It is not diagnostic but helps the doctor determine treatment options and understand more about the tumor's characteristics.

    Serum Her-2/neu is sometimes ordered initially to establish a baseline concentration and then, if elevated, ordered periodically to monitor cancer treatment. Occasionally it may be ordered to help determine a cancer's Her-2/neu status when there is insufficient tumor tissue available to perform tissue testing.

  • What does the test result mean?

    If an IHC Her-2/neu test is positive, it means that the Her-2/neu gene is over-expressing the Her-2/neu protein. If a FISH test is done, then amplification of the Her-2/neu gene can be detected. If either of these is positive, then the person is likely to have a tumor that is aggressive, that will respond poorly to endocrine treatment, and that will be resistant to chemotherapy. These people may be considered candidates for tratuzumab (Herceptin) therapy, a drug that was created to target Her-2/neu protein.

    If the IHC is negative but the FISH is positive, the person still may benefit from Herceptin, but if both are negative the treatment will not be useful.

    If a breast cancer is Her-2/neu-positive and the serum Her-2/neu is initially elevated, then changes in serum Her-2/neu levels can be used to help monitor the effectiveness of Herceptin treatment and detect early disease progression. Decreases indicate a response to treatment; levels that stay the same or increase indicate that the treatment is not effective; concentrations that fall, then rise may indicate a cancer recurrence. If the serum Her-2/neu is initially negative or low, such as may be seen with early cancers and with Her-2/neu-negative cancers, then it may not be useful as a monitoring tool.

    Some studies have shown that there can be differences in Her-2/neu positivity between the primary tumor and tumor that has spread to other parts of the body. If a patient who has metastatic breast cancer is determined to be Her-2/neu negative when the primary tumor is tested but then has a serum Her-2/neu level greater than 15 ng/mL, then additional testing of tissue may be indicated.

  • Is there anything else I should know?

    Her-2/neu-positive tumors are susceptible to Herceptin (tratuzumab). Herceptin attaches itself to the excess protein molecules and inhibits the growth of the cancer. The development of this specialized therapy has increased the use of Her-2/neu testing. Herceptin may be used alone or with some chemotherapy agents but is only useful in those who have Her-2/neu amplification and protein over-expression.

    Her-2/neu testing is not available in every laboratory. Both IHC and FISH require experience and special training to perform and interpret. Your doctor will probably send your sample to a reference laboratory and the results may take several weeks to return.

    It takes a small amount of cancer tissue to perform the Her-2/neu test. If a sufficient sample is not available, your doctor may try running a serum Her-2/neu test and/or make an assumption that you are Her-2/neu-positive in order to broaden your treatment options.

    The Her-2/neu gene is also amplified and its protein is over-expressed with some other cancers, such as ovarian and bladder cancer.

  • Besides Her-2/neu, what other laboratory tests may my doctor be ordering on my breast cancer tissue?

    During an initial workup of invasive breast cancer, your doctor will likely do a tissue test for hormone receptor status. A patient with a positive estrogen and/or progesterone receptor status may find their response to endocrine/hormone therapy diminished if they are also Her-2/neu-positive, limiting that treatment option.

  • Does Herceptin work for everyone who is Her-2/neu positive?

    Unfortunately, no. Only about one-third of patients who are positive for Her-2/neu will respond to Herceptin therapy. There are other cellular factors involved that are not well understood yet. Herceptin is sometimes combined with other chemotherapy agents to make it more effective.

  • Would this testing also be performed on a man?

    Yes. Men do not get breast cancer as frequently as women, but it does occur and their cancer may also be Her-2/neu-positive. In addition, there are some data that Her-2/neu can help determine a prognosis in prostate cancer in men.

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