2020
DOI: 10.1186/s13063-019-3643-6
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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

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 met… Show more

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Cited by 13 publications
(10 citation statements)
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“…This emphasizes the need for evaluating the role of radium-223 earlier in the disease course and in combination with systemic agents. Different trials are currently evaluating the efficacy of radium-223 in breast cancer in combination with paclitaxel (NCT04090398), endocrine treatments (aromatase inhibitors plus everolimus; NCT02258451), and capecitabine (ISRCTN92755158) ( 8 ).…”
Section: Discussionmentioning
confidence: 99%
“…This emphasizes the need for evaluating the role of radium-223 earlier in the disease course and in combination with systemic agents. Different trials are currently evaluating the efficacy of radium-223 in breast cancer in combination with paclitaxel (NCT04090398), endocrine treatments (aromatase inhibitors plus everolimus; NCT02258451), and capecitabine (ISRCTN92755158) ( 8 ).…”
Section: Discussionmentioning
confidence: 99%
“…In another study, breast cancer patients with predominant bone disease underwent 223 Ra therapy with metabolic activity reduction of lesions and a good safety profile [ 100 ]. CARBON trial, registered o 2016, is investigating a possible combination of 223 Ra and capecitabine in terms of safety and disease control for metastatic breast cancer patients with bone involvement [ 101 ]. Limitations of radiopharmaceuticals is their myelosuppressive persistent effect and indication to use principally in the palliative setting.…”
Section: Co-adjuvant Systemic Therapies and Focal Alternatives To mentioning
confidence: 99%
“…Not surprisingly, [ 223 Ra]RaCl is the subject of ongoing trials in other bone dominant metastatic cancers such as breast [ 140 , 141 ] and lung cancers [ 142 ]. In a phase II trial, [ 223 Ra]RaCl has been administered with different hormonal therapy agents [ 141 ].…”
Section: [223 Ra]radium-dichloride ([ 223 Ra]rmentioning
confidence: 99%
“…The primary end-point was disease control at 9 months, achieved in 49% of patients [ 141 ]. In addition, the study evaluating the efficacy of combined therapy of [ 223 Ra]RaCl in association with hormonal therapy and a chemotherapy drug (capecitabine) is still in progress [ 140 ].…”
Section: [223 Ra]radium-dichloride ([ 223 Ra]rmentioning
confidence: 99%