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Herceptin FAQs

Herceptin Frequently Asked Questions (FAQs)

  • Q: What is Herceptin?
  • A: Herceptin (trastuzumab) is a treatment for women with breast cancer whose tumors have too much HER2 protein. This type of cancer is known as "HER2-positive", "HER2+", or "HER2 overexpressing". HER2+ tumors tend to grow and spread more quickly than tumors that are not HER2+. This is why it is so important to find out your cancer's HER2 status.

    Clinical experience with Herceptin for the adjuvant treatment of HER2+ breast cancer began in 2000. In 2006, Herceptin was approved for the adjuvant treatment of HER2+ breast cancer.

    Herceptin is approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer. Herceptin can be used several different ways:
    • As part of a treatment regimen including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
    • With docetaxel and carboplatin
    • As a single agent following multi-modality anthracycline-based therapy

    Herceptin in combination with paclitaxel is approved for the first-line treatment of HER2-overexpressing metastatic breast cancer. Herceptin as a single agent is approved for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

    Herceptin is not chemotherapy or hormonal therapy. Herceptin is a type of targeted cancer therapy known as a monoclonal antibody (sometimes called targeted biologic therapy). Antibodies are part of the body's normal defense against bacteria, viruses, and abnormal cells, such as cancer cells.

    • Monoclonal antibodies are produced in a laboratory by making multiple copies of a single cell. Monoclonal antibodies are designed to recognize a specific protein on certain cells and signal the body's immune system to destroy the cell.
    • Monoclonal antibodies are generally a more targeted form of therapy than chemotherapy.

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  • Q: How does Herceptin work?
  • A: Herceptin is designed to target HER2+ cancer cells. Based on laboratory studies, Herceptin works 2 ways to stop the HER2+ cancer cell from growing.

    • Herceptin attaches to a HER2+ cancer cell and tells your body's defense system to target the HER2+ cancer cell
    • Herceptin also stops the HER2+ cancer cell from telling itself to grow and divide into more cancer cells

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  • Q: Who may benefit from Herceptin?
  • A: Herceptin is a treatment for women with breast cancer whose tumors have too much HER2 protein. This type of cancer is known as "HER2-positive", "HER2+", or "HER2 overexpressing". HER2+ tumors tend to grow and spread more quickly than tumors that are not HER2+. This is why it is so important to find out your cancer's HER2 status.

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  • Q: What does it mean when the breast cancer is HER2-positive?
  • A: HER2 stands for Human Epidermal growth factor Receptor 2. Each normal breast cell contains copies of the HER2 gene, which helps normal cells grow. The HER2 gene is found in the DNA of a cell, and this gene contains the information for making the HER2 protein.

    The HER2 protein, also called the HER2 receptor, is found on the surface of some normal cells in the body. In normal cells, HER2 proteins help send growth signals from outside the cell to the inside of the cell. These signals tell the cell to grow and divide.

    In HER2+ breast cancer, the cancer cells have an abnormally high number of HER2 genes per cell. When this happens, too much HER2 protein appears on the surface of these cancer cells. This is called HER2 protein overexpression. Too much HER2 protein is thought to cause cancer cells to grow and divide more quickly. This is why HER2+breast cancer is considered aggressive.

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  • Q: How do I know if my breast cancer is HER2-positive?
  • A: Women who are uncertain of their cancer's HER2 status should talk to their doctor. For Herceptin, there are now 2 types of tests available to determine HER2 status: IHC and FISH.

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  • Q: How has Herceptin been studied for the adjuvant treatment of HER2+ breast cancer?
  • A: Herceptin has been studied in four large clinical trials of over 10,000 women. Patients participating in the clinical trials received either Herceptin plus chemotherapy or chemotherapy alone. In addition to chemotherapy, some patients in these trials received radiation therapy, and some received hormonal therapy depending on their type of tumor.

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  • Q: What have studies with Herceptin for HER2-positive metastatic breast cancer found?
  • A: Herceptin has been studied in a large clinical trial in people with HER2-positive metastatic breast cancer. People participating in the clinical trial received either chemotherapy plus Herceptin or chemotherapy alone. A clinical trial is a test of a treatment to see if it is beneficial to a particular group of people. If a treatment works well in an extensive clinical trial, it may become a new therapy that can help many people with cancer. In the Herceptin clinical trial, some people received chemotherapy plus Herceptin, while others received just chemotherapy. People who received Herceptin plus chemotherapy benefited in important ways. While results may vary, on average, people who received Herceptin plus chemotherapy:

    • Lived longer than those who received chemotherapy alone.
    • Their cancer was kept from growing for a longer time compared with those who received chemotherapy alone.
    • Their tumors shrank in size more often than those who received chemotherapy alone.
    Herceptin does have possible side effects. In clinical trials, some people receiving Herceptin in combination with chemotherapy experienced serious side effects. It's important to discuss treatment benefits and risks with your doctor and to have realistic expectations of Herceptin therapy.

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  • Q: How do I take Herceptin?
  • A: Herceptin is given through an intravenous (IV) infusion at your doctor's office or clinic.
    • The first infusion usually takes about 90 minutes but may be slowed or stopped if you have discomfort from side effects.
    • As long as the prior infusion was well tolerated, later infusions should last only about 30 minutes.

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  • Q: How long should I take Herceptin for the adjuvant treatment of HER2+ breast cancer?
  • A: Herceptin is recommended to be taken for 1 year. There are dosing options available.
    • Weekly: You may receive Herceptin weekly, when it is started with chemotherapy.
    • Every three weeks: You may receive Herceptin on its own once every three weeks, after surgery and chemotherapy have been finished.
    Talk to your health care team to decide which dosing option works best for you and your lifestyle.

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  • Q: How long should I continue therapy with Herceptin in the treatment of HER2-positive metastatic breast cancer?
  • A: In the clinical trial that demonstrated the benefits of Herceptin, metastatic breast cancer patients continued to receive Herceptin even if their chemotherapy was stopped (and until their cancer started to grow again.)

    Talk to your doctor about how long you should stay on Herceptin therapy.

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  • Q: Is Herceptin covered by my insurance?
  • A: Herceptin Access Solutions™ is a reimbursement resource designed to address the informational needs of patients on Genentech products related to reimbursement. Herceptin Access Solutions provides information to doctors, on their patient's behalf, in order to help obtain timely reimbursement.

    Herceptin Access Solutions provides personalized professional information regarding insurance:

    • billing issues
    • policy benefits
    • coverage requirements
    • appeals of coverage denials
    • resources for locating independent, public charities for the purpose of co-pay assistance
    • For more information, visit us at
    • http://www.HerceptinAccessSolutions.com,
    • or contact us at:
    • Toll-free: 1-888-249-4918
    • Fax: 1-888-249-4970

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  • Q: Can I take Herceptin with my other cancer treatments?
  • A: Yes, Herceptin can be given with other cancer treatments. Remember, Herceptin is not chemotherapy or hormonal therapy. The potential benefits of Herceptin are in addition to the potential benefits you may receive from surgery, chemotherapy, hormonal therapy, or radiation therapy. Herceptin is not a substitute for any of these therapies. Talk to your doctor about what therapies are right for you.

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  • Q: When was Herceptin approved by the FDA?
  • A: In 1998, Herceptin was approved for the treatment of HER2+ metastatic breast cancer. In 2006, the FDA approved Herceptin for the adjuvant treatment of patients with HER2+ breast cancer.

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  • Q: When did testing for a tumor's HER2 status become standard?
  • A: The first test that determined a tumor's HER2 status was approved in 1998. A tumor's HER2 status is now recognized as an important factor in determining the appropriate treatment for a patient with breast cancer.

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  • Q: What should I look out for when I'm on Herceptin therapy, and what symptoms should I immediately report to my doctor?
  • A: Be sure to tell your doctor about any health conditions you have had, as well as any new symptoms that arise. Call your doctor immediately if you have any of the following: new or worsening shortness of breath; cough; swelling of the ankles or legs; swelling of the face; heartbeats that are unusually strong, fast, slow, or irregular in rhythm; weight gain of more than 5 pounds in 24 hours; dizziness; or loss of consciousness.

    Individual patients may experience different side effects. If you have questions or health concerns, please talk to your doctor or nurse.

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  • Q: Is HER2 status hereditary?
  • A: Your tumor's HER2 status is not hereditary. This means that HER2 status is not passed down from your parents, and you can't pass it on to your children. However, there is a relationship between the genes in a person's DNA and breast cancer in general. Ask your doctor for more information about the relationship between genes and breast cancer.

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  • Q: Can I drive after my Herceptin treatment?
  • A: During the period you are taking both chemotherapy and Herceptin, you will have to discuss with your doctor or nurse whether you will be able to drive home after your infusion. After chemotherapy has been completed, and you are taking Herceptin alone, you will likely be able to drive home from your treatment. Everyone is different, however. It is not possible to predict whether you will feel well enough to drive after each infusion. Talk to your doctor or nurse.

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  • Q: Can I take Herceptin if I am pregnant?
  • A: Herceptin can cause harm to the fetus when taken by a pregnant woman. This may be related to a lowering of amniotic fluid levels in the second and third trimesters.

    You should use effective contraceptive methods while receiving Herceptin and for at least 6 months after you finish taking Herceptin.

    Talk to your doctor if you are pregnant or become pregnant while taking Herceptin. If you are pregnant and receiving Herceptin, consider joining the Cancer and Childbirth Registry by calling 1-800-690-6720. By joining this registry, you can help others understand the effects of taking Herceptin while pregnant.

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  • Q: Is Herceptin right for me?
  • A: Because everyone is different, it is not possible to predict what side effects any one person will have, or whether Herceptin treatment will be effective for you. It's important to discuss potential treatment benefits and risks with your doctor and to have realistic expectations of Herceptin therapy.

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Herceptin® (trastuzumab)Herceptin® (trastuzumab)

Adjuvant Care Is defined as additional treatment given after the main treatment plan to decrease the chance of recurrence. Adjuvant therapy for breast cancer can include chemotherapy, hormone therapy, radiation therapy, or biological therapy

Metastatic Breast Cancer Breast cancer that has spread to other sites in the body; also referred to as invasive or infiltrating

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