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Possible Benefits of Herceptin

Herceptin has been studied for the adjuvant treatment of HER2+ breast cancer1

Herceptin (trastuzumab) has been studied as an adjuvant treatment for HER2+ breast cancer in four large clinical trials including a total of more than 10,000 women. All of the women in these studies received chemotherapy. They also received hormonal therapy and/or radiation therapy if it was thought to be helpful for their treatment. About half the women received Herceptin, while the other half did not.

Four adjuvant trials of over 10,000 women showed Herceptin benefit1

Women who received one year of Herceptin had a lower risk of cancer returning than women who did not receive Herceptin.

In two of the trials, Herceptin was started with chemotherapy (paclitaxel) after patients finished another chemotherapy regimen (doxorubicin and cyclophosphamide). When looking at the entire population of women in both of these trials.

  • Women who received Herceptin with chemotherapy had a 52% lower risk of breast cancer returning compared with those who received chemotherapy alone

In the third trial, Herceptin was given on its own after surgery and chemotherapy.

  • Women who received Herceptin had a 46% lower risk of breast cancer returning than those who did not receive Herceptin

In the fourth trial, Herceptin was started with different kinds of chemotherapies. Some women received Herceptin with chemotherapies called docetaxel and carboplatin.

  • Women who received this treatment had a 33% lower risk of breast cancer returning compared with those who received chemotherapy alone

For some women in the fourth trial, Herceptin was started with chemotherapy (docetaxel) following completion of another chemotherapy regimen (doxorubicin and cyclophosphamide).

  • Women who received this treatment had a 40% lower risk of breast cancer returning compared with those who received chemotherapy alone

The potential benefits received from Herceptin were in addition to those received from surgery, chemotherapy, radiation, and hormonal therapy.

Every person who has HER2+ breast cancer is unique, and no cancer treatment works for every person. Your experience may be different from those of the women who participated in the clinical trials. Further, because of the aggressive nature of HER2+ breast cancer, the status of these women may change over time.

What important safety information should I know about Herceptin?

Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). The risk and seriousness of these heart problems were highest in people who received both Herceptin and a certain type of chemotherapy (anthracycline). Your doctor will stop or strongly consider stopping Herceptin if you have a significant drop in your heart function.

You should be monitored for decreased heart function before your first dose of Herceptin, and frequently during the time you are receiving Herceptin and after your last dose of Herceptin. If you must permanently or temporarily stop Herceptin due to heart problems, you should be monitored more frequently. In one study with Herceptin and certain types of chemotherapy, an inadequate blood supply to the heart occurred.

Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. In most cases, these reactions occurred during or within 24 hours of receiving Herceptin. Your Herceptin infusion should be temporarily stopped if you have shortness of breath or very low blood pressure. Your doctor will monitor you until these symptoms go away. If you have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath, your doctor may need to completely stop your Herceptin treatment.

Worsening of low white blood cell counts associated with chemotherapy has also occurred.

Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman.

The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain.

Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor.

Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.

  • References:
  • 1. Herceptin® (trastuzumab) Full Prescribing Information, Genentech, Inc. May 2008.
  • 2. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2+ breast cancer. N Engl J Med. 2005; 353: 1673-1684 and supplementary appendix.


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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