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Herceptin trials in early breast cancer

This page tells you about research into using trastuzumab (Herceptin) for early breast cancer to try to stop the cancer from coming back. There is information about


What Herceptin is

Trastuzumab (Herceptin) is a biological cancer treatment. It is a monoclonal antibody that attaches to the HER2 protein found on the cells of some breast cancers. Cancers that are HER2 positive tend to have a worse outlook than cancers that are HER2 negative. If the cells of your cancer aren't HER2 positive, Herceptin won’t help to treat it. Between 20 to 25 out of every 100 early breast cancers (20 to 25%) have the HER2 protein on their cells.


Trial results for Herceptin in early breast cancer

3 large trials looked into using Herceptin to treat HER2 positive early breast cancer. They aimed to try to stop the cancer from coming back. Two of the trials were American and one was a very large European and worldwide trial called HERA. The trials looked at giving Herceptin as well as chemotherapy to women after surgery to remove their breast cancer. The researchers wanted to see whether the combined treatment could reduce the risk of breast cancer coming back even more than chemotherapy on its own. This type of treatment is called adjuvant therapy.

All the trials were for women who had breast cancer that tested positive for HER2. And most of them had cancer spread to their lymph nodes. This meant that the women had a high risk of their breast cancer coming back. In the trials the women either had Herceptin after their chemotherapy or at the same time. The trials showed that the cancer came back in about half as many women when compared to chemotherapy given without Herceptin. But we’ll have to wait a few more years yet to get longer term results for all the women who took part.

A smaller fourth trial gave a short course of trastuzumab to women with lymph node positive tumours or tumours bigger than 2 cm. The women had drips (infusions) of trastuzumab once a week for 9 weeks with their chemotherapy. The risk of the cancer coming back and the risk of dying was significantly reduced in the women who had Herceptin.

It is important to know that Herceptin can cause heart problems in some women. This is more likely if you have had chemotherapy with a drug that also causes heart problems. Doxorubicin (adriamycin) is one such drug and it was used with Herceptin in the early breast cancer trials because it is particularly good at preventing breast cancer recurrence.

There are clinical trials looking at treating early breast cancer with Herceptin. There is a phase 3 trial called EPHOS B looking at the effect of having trastuzumab (Herceptin) or lapatinib before surgery. Research has shown that having Herceptin after surgery lowers the risk of the cancer coming back in people with HER2 positive breast cancer. The researchers want to find out if having drugs that work by blocking HER2 protein before surgery may lower the risk more.

Another phase 3 trial called SOLD is looking at having Herceptin with chemotherapy for early breast cancer. The aim of this trial is to compare having Herceptin with chemotherapy to the same treatment followed by continued Herceptin for one year.

There is another phase 3 trial called PERSEPHONE. This trial is comparing 6 months and 12 months of trastuzumab for early breast cancer. The aim of this trial is to find out if 6 months of treatment works as well as 12 months. As Herceptin can cause heart problems in some women, the researchers also want to find out if having treatment for a shorter time can help lower the risk of damage to the heart.

APHINITY is a phase 3 trial looking at Herceptin and pertuzumab for HER2 positive breast cancer. Pertuzumab is another monoclonal antibody that also targets the HER2 protein. The researchers want to find out if giving pertuzumab and Herceptin is better than Herceptin alone for people who have had surgery for HER2 positive breast cancer.


What we don’t know yet

Although Herceptin has been shown to reduce the chance of cancer coming back in women with HER 2 positive breast cancer, there are still some questions about how best to use Herceptin, such as

  • When is the best time to have Herceptin
  • How long to prescribe it for
  • Whether any long term risks of this treatment could outweigh the benefits for some women
  • Whether the treatment just delays the breast cancer coming back rather than preventing it altogether

To answer these questions, research into Herceptin for early breast cancer is continuing. For now, the National Institute for Health and Care Excellence (NICE) has said that doctors should give it 3 weekly for a year (after surgery, chemotherapy and radiotherapy has finished). They may revise this in future depending on new research results.


More information about Herceptin for early breast cancer

There is detailed information about the NICE guidance on Herceptin for early breast cancer on the biological therapy for early breast cancer page.

You can find out more about Herceptin trials for breast cancer on our clinical trials database. Choose 'breast cancer' from the dropdown menu of cancer types and type 'trastuzumab' into the text box. If you want to see all the trials, tick the boxes for closed trials and trial results.

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Updated: 2 September 2013