A trial looking at trastuzumab (Herceptin) with chemotherapy for early breast cancer (SOLD)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 3

This trial compared trastuzumab (Herceptin) and chemotherapy, to Herceptin and chemotherapy followed by more Herceptin. It was for women with early breast cancer that was HER2 positive. This trial was supported by Cancer Research UK.

More about this trial

Doctors often treat early breast cancer with surgery and chemotherapy. People with HER2 positive cancer may also have trastuzumab (Herceptin). HER2 positive cancer means that it has large amounts of a protein called human epidermal growth factor 2 receptor (HER2).

When this trial was done, the standard treatment was to have Herceptin for a year. But researchers hoped that having a shorter course of Herceptin at the same time as docetaxel chemotherapy would work as well. They also hoped it would cause fewer side effects.

Everyone taking part in this trial had:

docetaxel chemotherapy and Herceptin at the same time to start with, then
a combination of chemotherapy called FEC (fluorouracil, epirubicin and cyclophosphamide)

Some women then had more Herceptin, and some didn’t.

The aim of this trial was to compare Herceptin and chemotherapy, to Herceptin and chemotherapy followed by more Herceptin, to see which worked better.

Summary of results

The research team found that the cancer came back in a few more people who had Herceptin for 9 weeks, but that there wasn’t much difference in how long people lived.

This trial was open for people to join between 2008 and 2014. The research team analysed the results in 2016, and published them in 2018.

Results

The research team recruited more than 2,000 women with early stage breast cancer. They were put into 1 of 2 groups at random.

Everyone taking part had docetaxel chemotherapy and Herceptin for 9 weeks to begin with, then FEC chemotherapy. After that:

half didn’t have any more Herceptin
half had Herceptin for about another 10 months (so about a year in total)

The research team looked at how many people were living with no signs that their cancer had come back, 5 years after treatment. They found it was:

88% of those who’d had Herceptin for 9 weeks
91% of those who’d had Herceptin for a year

They also looked at how many people’s cancer had spread to another part of the body, and found it was:

73 women (7%) who’d had Herceptin for 9 weeks
61 women (6%) who’d had Herceptin for a year

When they looked at how many people had died of breast cancer they found it was:

34 women (3%) who’d had Herceptin for 9 weeks
33 women (3%) who’d had Herceptin for a year

The research team looked separately at how much docetaxel the women had, to see if this affected how well Herceptin worked. They found that when women had a higher dose of docetaxel, those who had Herceptin for 9 weeks did as well as those who had Herceptin for year.

Side effects

Herceptin can cause side effects including heart problems such as congestive heart failure (CHF). The number of women with heart related side effects was:

22 women (2%) who had Herceptin for 9 weeks
42 women (4%) who had Herceptin for a year

People who have Herceptin have regular tests to check for signs of heart problems. One of these is an echocardiogram, or echo. This is an ultrasound scan which measures how much blood the heart pumps each time it beats. A healthy heart pumps at least 55%. The results of this trial showed it was:

63% for women who had Herceptin for 9 weeks
61% for women who had Herceptin for a year

Conclusions

The research team concluded that the cancer started to grow again in a few more people who had Herceptin for 9 weeks. But how long people lived for was similar in both groups. And a few more people who had Herceptin for a year had heart related side effects.

The research team recommend that standard treatment should still be Herceptin for 1 year. They suggest that more work is done looking at having Herceptin with a higher dose of docetaxel.

Where this information comes from

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.