A trial looking at lapatinib, trastuzumab and chemotherapy before surgery for breast cancer (LAPATAX) (EORTC 10054)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 2

This trial looked at lapatinib, trastuzumab and chemotherapy before surgery for breast cancer. The trial was for women who have HER2 positive breast cancer. This means the cancer has large amounts of a protein called HER2.

If your breast cancer has spread into the surrounding tissue (is locally advanced), is inflammatory breast cancer or you have a large tumour, you may have chemotherapy before surgery. If your breast cancer is also HER2 positive you may have trastuzumab (Herceptin) before surgery. Although this works well doctors are always looking for ways to improve treatment.

More about this trial

One combination of chemotherapy that doctors use is fluorouracil (5FU), epirubicin and cyclophosphamide (this is called FEC). Docetaxel is another chemotherapy drug that doctors can use. If breast cancer cells produce large amounts of a protein called HER2 doctors can use biological therapies such as trastuzumab, which target HER2.

In this trial, doctors looked at trastuzumab and another drug called lapatinib alongside standard docetaxel and FEC chemotherapy. Lapatinib is another type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow. We know from research that it may help to treat breast cancers that don’t respond to trastuzumab.

In this trial, women had a combination of docetaxel, trastuzumab and lapatinib followed by FEC before surgery.

The aims of this trial were to

  • Find out how well this combination works when given before FEC
  • Find out if this combination is better than the usual treatment of docetaxel and trastuzumab followed by FEC
  • Learn more about the side effects

Summary of results

The researchers found that having both trastuzumab and lapatinib alongside docetaxel worked better than having docetaxel with either trastuzumab or lapatinib before surgery.

128 women took part in this trial. Of those,

  • 23 had docetaxel and lapatinib followed by FEC
  • 53 had docetaxel and trastuzumab followed by FEC
  • 52 had docetaxel, trastuzumab and lapatinib followed by FEC

The researchers looked at how well the treatment worked from the results for 122 women. They looked at whose cancer had gone away completely in the breast. They found this was

  • Just over 4 out of 10 women (46%) in the lapatinib group
  • Just over 5 out of 10 women  (52%) in the trastuzumab group
  • 6 out of 10 women (60%) in the group who had both

They also looked at whose cancer had gone away completely in the breast and lymph nodes. This was

  • Just under 4 out of 10 women (36%) in the lapatinib group
  • Just over 5 out of 10 women  (52%) in the trastuzumab group
  • Just under 6 out of 10 women (56%) in the group who had both

Women who had both trastuzumab and lapatinib had more side effects. These included diarrhoea and liver problems.

The trial team found that having both lapatinib and trastuzumab alongside docetaxel chemotherapy and before FEC helped women with HER2 positive breast cancer before surgery.

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed) and published in a medical journal. The figures we quote above were provided by the research team. We have not analysed the data ourselves.
 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Prof David Cameron

Supported by

European Organisation for Research and Treatment of Cancer (EORTC)
Experimental Cancer Medicine Centre (ECMC)
GlaxoSmithKline (GSK)
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9380

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Caroline took part in a clinical trial for breast cancer

“I had treatment last year and I want to give something back.”

Last reviewed:

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