CApecitabine plus Radium-223 (Xofigo) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
dc.contributor.author | Coleman, R | |
dc.contributor.author | Brown, J | |
dc.contributor.author | Rathbone, E | |
dc.contributor.author | Flanagan, L | |
dc.contributor.author | Reid, A | |
dc.contributor.author | Kendall, J | |
dc.contributor.author | Howell, Sacha J | |
dc.contributor.author | Twelves, C | |
dc.contributor.author | Palmieri, C | |
dc.contributor.author | Anand, A | |
dc.contributor.author | MacPherson, I | |
dc.contributor.author | Brown, S | |
dc.date.accessioned | 2020-02-27T16:55:22Z | |
dc.date.available | 2020-02-27T16:55:22Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Coleman R, Brown J, Rathbone E, Flanagan L, Reid A, Kendall J, et al. CApecitabine plus Radium-223 (Xofigo) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial. Trials. 2020;21(1):89. | en |
dc.identifier.pmid | 31941523 | en |
dc.identifier.doi | 10.1186/s13063-019-3643-6 | en |
dc.identifier.uri | http://hdl.handle.net/10541/622751 | |
dc.description.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. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1186/s13063-019-3643-6 | en |
dc.title | CApecitabine plus Radium-223 (Xofigo) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial | en |
dc.type | Article | en |
dc.contributor.department | The University of Sheffield, Sheffield, UK | en |
dc.identifier.journal | Trials | en |
dc.description.note | en] | |
refterms.dateFOA | 2020-03-03T14:05:31Z |