Coleman, R, Brown, J, Rathbone, E, Flanagan, L, Reid, A, Kendall, J, Howell, S, Twelves, C, Palmieri, C 
ORCID: 0000-0001-9496-2718, Anand, A et al (show 2 more authors)
(2020)
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): Study protocol for a phase IB/IIA randomised controlled trial
Trials, 21 (1).
89-.
ISSN 1745-6215, 1745-6215
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Text
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON) study protocol for a phase IB.pdf - Published version Download (1MB) | Preview |
Abstract
Background: A substantial proportion of breast cancer patients develop metastatic disease, with over 450,000 deaths globally per year. Bone is the most common first site of metastatic disease accounting for 40% of all first recurrence and 70% of patients with advanced disease develop skeletal involvement. Treatment of bone metastases currently focusses on symptom relief and prevention and treatment of skeletal complications. However, there remains a need for further treatment options for patients with bone metastases. Combining systemic therapy with a bone-targeted agent, such as radium-223, may provide an effective treatment with minimal additional side effects. Methods/design: CARBON is a UK-based, open-label, multi-centre study which comprises an initial safety phase to establish the feasibility and safety of combining radium-223 given on a 6-weekly schedule in combination with orally administered capecitabine followed by a randomised extension phase to further characterise the safety profile and provide preliminary estimation of efficacy. Discussion: The CARBON study is important as the results will be the first to assess radium-223 with chemotherapy in advanced breast cancer. If the results find acceptable rates of toxicity with a decrease in bone turnover markers, further work will be necessary in a phase II/III setting to assess the efficacy and clinical benefit. Trial registration: ISRCTN, ISRCTN92755158, Registered on 17 February 2016.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Radium-223, Capecitabine, Bone metastases, Bone turnover markers, Breast cancer |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 15 Feb 2021 08:36 |
| Last Modified: | 22 Jan 2026 08:18 |
| DOI: | 10.1186/s13063-019-3643-6 |
| Related Websites: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3115611 |
| Disclaimer: | The University of Liverpool is not responsible for content contained on other websites from links within repository metadata. Please contact us if you notice anything that appears incorrect or inappropriate. |
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