A trial looking at coumate for advanced breast cancer (PH1/096)

Cancer type:

Breast cancer

Status:

Results

Phase:

Phase 1

This trial looked at a new drug called coumate to treat hormone receptor positive breast cancer in women who have been through the menopause. This trial was supported by Cancer Research UK.

Coumate (or 667-coumate) is a type of drug called a sulphatase inhibitor. This means it stops an enzyme called sulphatase working properly. Sulphatase is important in the production of oestrogen in post menopausal women.

The theory is that if doctors can reduce the amount of oestrogen in the body, they can stop oestrogen receptor (ER) or progesterone receptor (PR) positive breast cancers growing.

In this trial, the researchers took samples of blood and cancer tissue (a biopsy) from each patient after they had had treatment.

The aims of this trial were to find out

What effect coumate had on the levels of sulphatase and oestrogen in the body
The best dose of coumate to use
What the side effects are

Summary of results

The research team found that coumate was safe, and that it may be a useful treatment for post menopausal women with ER or PR positive breast cancer in the future.

This was a very small trial. It recruited 14 patients who had already had treatment for breast cancer. 5 had a lower dose of coumate, and 9 had a higher dose.

Only 8 patients had all 16 doses of coumate as planned. The other 6 stopped treatment part way through because their cancer had continued to grow.

Of the 14 who took part, the research team were able to analyse the blood and tissue samples of 10. They looked at the results in early 2005.

They found that

The level of sulphatase in the blood and tissue samples was almost 0 in most patients
The levels of hormones were significantly reduced
The cancer stopped growing in 4 patients (researchers call this ‘stable disease ’)

The side effects were generally mild. The most common side effect was a change in taste, but for most people this only lasted a few hours or so.

The research team concluded that coumate was safe and could be a useful treatment in this group of patients.

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.