التفاصيل البيبلوغرافية
| العنوان: |
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial. |
| 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 |
| المصدر: |
Trials; 1/15/2020, Vol. 21 Issue 1, p1-10, 10p, 2 Diagrams, 1 Chart |
| مصطلحات موضوعية: |
BONE metastasis, BONE cancer, BREAST cancer, CANCER patients, CANCER chemotherapy, DRUG labeling, LABELS, THERAPEUTIC use of lithium, HOLMIUM |
| مصطلحات جغرافية: |
UNITED Kingdom |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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