CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial

Coleman, R. et al. (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, 89. (doi: 10.1186/s13063-019-3643-6) (PMID:31941523) (PMCID:PMC6961242)

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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:Articles
Additional Information:The study is funded by Bayer Healthcare and supported by YCR. The research is supported by the National Institute for Health Research (NIHR) infrastructure at Leeds.
Glasgow Author(s) Enlighten ID:MacPherson, Professor Iain
Authors: Coleman, R., Brown, J., Rathbone, E., Flanagan, L., Reid, A., Kendall, J., Howell, S., Twelves, C., Palmieri, C., Anand, A., MacPherson, I., and Brown, S.
College/School:College of Medical Veterinary and Life Sciences > School of Cancer Sciences
Journal Name:Trials
Publisher:BioMed Central
ISSN (Online):1745-6215
Copyright Holders:Copyright © 2020 The Authors
First Published:First published in Trials 21: 89
Publisher Policy:Reproduced under a Creative Commons License

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