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

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    Authors
    Coleman, R
    Brown, J
    Rathbone, E
    Flanagan, L
    Reid, A
    Kendall, J
    Howell, Sacha J
    Twelves, C
    Palmieri, C
    Anand, A
    MacPherson, I
    Brown, S
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    Affiliation
    The University of Sheffield, Sheffield, UK
    Issue Date
    2020
    
    Metadata
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    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.
    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.
    Journal
    Trials
    URI
    http://hdl.handle.net/10541/622751
    DOI
    10.1186/s13063-019-3643-6
    PubMed ID
    31941523
    Additional Links
    https://dx.doi.org/10.1186/s13063-019-3643-6
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1186/s13063-019-3643-6
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