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About:
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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An Entity of Type :
schema:ScholarlyArticle
, within Data Space :
wasabi.inria.fr
associated with source
document(s)
Type:
Academic Article
research paper
schema:ScholarlyArticle
New Facet based on Instances of this Class
Attributes
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type
Academic Article
research paper
schema:ScholarlyArticle
isDefinedBy
Covid-on-the-Web dataset
has title
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
Creator
Anand, Anjana
Brown, Janet
Brown, Sarah
Coleman, Rob
Flanagan, Louise
Howell, Sacha
Kendall, Jessica
Macpherson, Iain
Palmieri, Carlo
Rathbone, Emma
Reid, Amber
Twelves, Chris
Source
PMC
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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3643-6) contains supplementary material, which is available to authorized users.
has issue date
2020-01-15
(
xsd:dateTime
)
bibo:doi
10.1186/s13063-019-3643-6
bibo:pmid
31941523
has license
cc-by
sha1sum (hex)
71f4295cec1e88caa3b0efa23eda0b0ba6d7c1a6
schema:url
https://doi.org/10.1186/s13063-019-3643-6
resource representing a document's title
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
has PubMed Central identifier
PMC6961242
has PubMed identifier
31941523
schema:publication
Trials
resource representing a document's body
covid:71f4295cec1e88caa3b0efa23eda0b0ba6d7c1a6#body_text
is
schema:about
of
named entity 'develop'
named entity 'substantial'
named entity 'accounting'
named entity 'extension'
named entity 'provide'
named entity 'safety'
named entity 'randomised controlled trial'
named entity 'RADIUM-223'
named entity 'SITE OF'
named entity 'METASTATIC DISEASE'
named entity 'skeletal'
named entity 'estimation'
named entity 'orally administered'
named entity 'radium'
named entity 'common'
named entity 'bone metastases'
named entity 'Background'
named entity 'weekly'
named entity 'options'
named entity 'combination'
named entity 'bone metastases'
named entity 'CARBON'
named entity 'breast cancer'
named entity 'radium-223'
named entity 'CARBON'
named entity 'BONe metastases'
named entity 'breast cancer'
named entity 'spinal cord compression'
named entity 'bladder'
named entity 'endocrine'
named entity 'radium-223'
named entity 'Bone Metastases'
named entity 'safety profile'
named entity 'SAEs'
named entity 'radium-223'
named entity 'metastasis'
named entity 'kidneys'
named entity 'paclitaxel'
named entity 'radium-223'
named entity 'phase II'
named entity 'CARBON'
named entity 'PSA'
named entity 'Radium-223'
named entity 'voided urine'
named entity 'NYHA'
named entity 'capecitabine'
named entity 'breast cancer'
named entity 'Gastrointestinal'
named entity 'Clinical Trials'
named entity 'morbidity'
named entity 'DLTs'
named entity 'hormone-refractory prostate cancer'
named entity 'radionuclide'
named entity 'warfarin'
named entity 'myelotoxicity'
named entity 'bone scintigraphy'
named entity 'hypercalcaemia'
named entity 'hazard ratio'
named entity 'Kaplan-Meier method'
named entity 'blood transfusion'
named entity 'sample size'
named entity 'quality-of-life'
named entity 'carcinoma in situ'
named entity 'bone metastases'
named entity 'radium-223'
named entity 'myelodysplasia'
named entity 'malabsorption'
named entity 'hormone-refractory prostate cancer'
named entity 'bone metastases'
named entity 'radium-223'
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