A trial looking at chemotherapy after surgery for breast cancer (TACT 2)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared 2 weekly with 3 weekly epirubicin followed by either CMF or capecitabine, after surgery for breast cancer.

Cancer Research UK supported this trial.

More about this trial

The usual treatment for early breast cancer is surgery. Some people might have chemotherapy after surgery. One combination of chemotherapy for breast cancer is epirubicin followed by:

cyclophosphamide
methotrexate
5FU (fluorouracil)

This combination of drugs is called CMF. This was the standard treatment when this trial was done.

Some people have epirubicin every 3 weeks. Before this trial had started, some research showed that having chemotherapy every 2 weeks might improve outcome. This is called accelerated treatment. But researchers weren’t sure if accelerated treatment would improve the effect on the cancer. So they wanted to find out more.

In this trial, they also looked at another chemotherapy drug called capecitabine. They thought it might work as well as CMF and have fewer side effects. But again they weren’t sure, so wanted to find out more.

The main aims of the trial were to find out:

if having epirubicin every 2 weeks worked as well as the usual 3 weekly treatments
if having capecitabine worked as well as CMF
more about side effects and quality of life

Summary of results

The trial team found no difference in having epirubicin every 2 weeks compared with having it every 3 weeks. However, they found that capecitabine could be used as an alternative to CMF. It caused fewer side effects and improved quality of life.

4,391 people (4,371 women and 20 men) took part in this phase 3 trial.

It was a randomised trial. The people were put into 1 of the 4 following treatments groups:

1,116 had epirubicin every 3 weeks followed by CMF
1,086 had epirubicin every 2 weeks followed by CMF
1,105 had epirubicin every 3 weeks followed by capecitabine
1,084 had epirubicin every 2 weeks followed by capecitabine

People who had 2 weekly epirubicin also had G-CSF Open a glossary item to help their white blood cells recover more quickly.

study diagram

The researchers followed people for an average of 7 years (85.6 months). At 5 years, the cancer hadn’t come back in 85 out of 100 people (85%).

2 weekly compared with 3 weekly epirubicin
The researchers looked at whether 2 weekly epirubicin increased the length of time before the cancer came back (recurred) compared with having it 3 weekly. They found no difference between the 2 groups.

They also looked at the side effects in both groups.

With 3 weekly epirubicin, the most common severe side effects were:

a drop in the number of white blood cells (neutropenia)
tiredness (fatigue)

With 2 weekly epirubicin the most common severe side effects were:

tiredness (fatigue)
infection

The 2 weekly group had more side effects overall. These included milder (low grade) side effects such as:

tingling, numb or sore hands and feet
a drop in the number of red blood cells (anaemia)

They also reported a worse quality of life than those who had 3 weekly treatment, although this difference did not persist after treatment finished.

The most common side effects for both groups were:

feeling sick
hair loss

The trial team concluded that having 2 weekly epirubicin did not improve the effect on the cancer or quality of life.

CMF compared with capecitabine
The researchers looked at those people whose cancer came back (recurred) and when this happened. They found there was no difference in recurrence between these 2 groups.

Overall, people having CMF had more severe side effects such as:

feeling sick (nausea)
infection
blood clots
anaemia

They reported a worse quality of life at the end of treatment than those who had capecitabine. This difference continued 12 and 24 months after treatment had finished.

People taking capecitabine had more problems with:

hand foot syndrome (palmar plantar syndrome)
diarrhoea
tingling or numbness in hands or feet

There was no difference in recurrence between those who had capecitabine and those who had CMF. Capecitabine had fewer side effects and improved quality of life.

We have based this summary on information from the research team. 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 who did the research. We have not analysed the data ourselves.