A trial looking at treatment for post menopausal women with breast cancer (DEVA trial)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial looked at epirubicin chemotherapy, with or without docetaxel for post menopausal women with breast cancer. It also tried to find out the best time to start hormone therapy for these women.

Many women have chemotherapy after their surgery for breast cancer. This is to reduce the risk of the cancer coming back. Doctors use many different drugs and combinations of drugs. This trial compared giving a drug called epirubicin on its own, with epirubicin followed by another drug called docetaxel. The researchers wanted to see which was better at stopping the cancer from coming back after surgery.

There is a slight increase in risk of a blood clot if you begin tamoxifen when you are having chemotherapy. This trial also tried to find out if beginning tamoxifen after your chemotherapy had finished reduced this risk.

Summary of results

The trial team found that epirubicin followed by docetaxel may be better at stopping breast cancer coming back than epirubicin alone.

This trial recruited 803 people. It was a randomised trial Open a glossary item . The people were put into 1 of 2 groups.

In group 1, there were 397 people. They had epirubicin for 6 cycles of treatment.

In group 2, there were 406 people. They had epirubicin for 3 cycles followed by docetaxel for 3 cycles.

After an average of 5 years follow up, the researchers looked at the number of people whose cancer had not come back. For those in group 1, it was about 73 people out of every 100 (73%). For those in group 2, it was about 80 people out of every 100 (80%).

Overall the number of people alive at 5 years was

About 82 people out of every 100 (82%) in group 1
About 90 people out of every 100 (90%) in group 2

People in group 2 had more side effects than people in group 1. But the researchers did not find any difference in the quality of life Open a glossary item between the 2 groups.

378 people agreed to take part in the tamoxifen study. Half started taking their tamoxifen when they started chemotherapy. The other half started taking it after they had finished their chemotherapy. Overall the research team found no difference in the number of blood clots each group had.

The researchers concluded that epirubicin followed by docetaxel could improve the outcome for post menopausal women with breast cancer.

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