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(1): 89, 2020 Jan 15.
Article
in En
| MEDLINE
| ID: mdl-31941523
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bone Neoplasms
/
Breast Neoplasms
/
Radium
/
Capecitabine
Type of study:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limits:
Female
/
Humans
Language:
En
Journal:
Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2020
Document type:
Article
Affiliation country:
Reino Unido