دورية أكاديمية
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
العنوان: | 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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المؤلفون: | Coleman, Rob, Brown, Janet, Rathbone, Emma, Flanagan, Louise, Reid, Amber, Kendall, Jessica, Howell, Sacha, Twelves, Chris, Palmieri, Carlo, Anand, Anjana, MacPherson, Iain, Brown, Sarah |
بيانات النشر: | BioMed Central |
سنة النشر: | 2020 |
المجموعة: | University of Glasgow: Enlighten - Publications |
الوصف: | 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. |
نوع الوثيقة: | article in journal/newspaper |
وصف الملف: | text |
اللغة: | English |
العلاقة: | http://eprints.gla.ac.uk/208004/1/208004.pdfTest; 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) |
الإتاحة: | https://doi.org/10.1186/s13063-019-3643-6Test http://eprints.gla.ac.uk/208004Test/ http://eprints.gla.ac.uk/208004/1/208004.pdfTest |
حقوق: | cc_by_4 |
رقم الانضمام: | edsbas.402DD627 |
قاعدة البيانات: | BASE |
الوصف غير متاح. |