A trial looking at capecitabine and radium-223 for advanced breast cancer (CARBON)
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This trial looked at capecitabine and a type of internal radiotherapy called radium-223. It was for women with breast cancer that had spread to the bones.
The study was open for people to join between 2016 and 2019. The team published the results in 2022.
More about this trial
Breast cancer can sometimes spread to other parts of the body, including to the bones. When this trial was done, doctors often used capecitabine (Xeloda) to treat breast cancer that had spread to the bones. Capecitabine is a chemotherapy drug.
Researchers wanted to find out if radium-223 (Xofigo) is a useful treatment for people in this situation.
Radium-223 is a type of internal radiotherapy. The cancer cells in the bone take up the radium-223. Once it’s in the bones, it releases radiation which can help kill cancer cells.
They hoped that using radium-223 and capecitabine together would work well.
The main aims of this trial were to find out:
- how well capecitabine with radium-223 works
- more about the side effects of capecitabine with radium-223
Summary of results
This trial was for people with breast cancer that had spread to their bones. They were due to have chemotherapy.
The trial had 2 parts.
In part 1 they looked for the safest dose of capecitabine and radium-223 to use. Everyone in this part had both capecitabine and radium-223.
In part 2 they looked at how well it worked as a treatment. People in this part were put into a treatment group at random. Some people had capecitabine and radium-223. And some people had capecitabine alone.
Results
A total of 34 people joined this trial:
- 23 people had capecitabine and radium-223
- 11 people had capecitabine alone
The research team found that no one in part 1 had any side effects that suggested the dose of treatment they were having was too high.
They looked at several factors to assess how well treatment was working. These included:
- the length of time before the cancer got worse
- any symptoms caused by cancer in the bones
- levels of various proteins that show the growth and breakdown of bone cells
They found these were all similar in people who had radium-223 and capecitabine, and those who had capecitabine alone.
Side effects
Most people taking part had at least 1 side effect. Many of these were mild or didn’t last long. But some people in each group had a side effect that was more severe.
The number of people with side effects such as diarrhoea, nausea, a sore mouth or a drop in blood cells was similar in both groups.
We have more information about the side effects of capecitabine and internal radiotherapy in our Treatment for cancer section.
Conclusion
The research team concluded that having radium-223 as well as capecitabine was safe. They also concluded it wasn’t better than capecitabine alone for breast cancer that has spread to the bones. But all trial results help doctors and researchers understand more about different cancers and the best way to treat them.
More detailed information
There is more information about this research in the reference below.
Please note, this article is not in plain English. It has been written for health care professionals and researchers.
A phase IB and randomised phase IIA trial of CApecitabine plus
Radium-223 (Xofigo™) in breast cancer patients with BONe metastases:
CARBON trial results
M Winter and others
Journal of Bone Oncology, 2022. Volume 35, article 100442.
Where this information comes from
We have based this summary on the information in the article above. This has been reviewed by independent specialists () and published in a medical journal. We have not analysed the data ourselves. As far as we are aware, the link we list above is active and the article is free and available to view.
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.
Chief Investigator
Professor Janet Brown
Supported by
Bayer
Experimental Cancer Medicine Centre (ECMC)
Yorkshire Cancer Research
NIHR Clinical Research Network: Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
University of Leeds
University of Sheffield
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040