CApecitabine plus Radium-223 (Xofigo) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
Authors
Coleman, RBrown, J
Rathbone, E
Flanagan, L
Reid, A
Kendall, J
Howell, Sacha J
Twelves, C
Palmieri, C
Anand, A
MacPherson, I
Brown, S
Affiliation
The University of Sheffield, Sheffield, UKIssue Date
2020
Metadata
Show full item recordAbstract
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
TrialsDOI
10.1186/s13063-019-3643-6PubMed ID
31941523Additional Links
https://dx.doi.org/10.1186/s13063-019-3643-6Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1186/s13063-019-3643-6