CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial.
Administration, Oral
Antimetabolites, Antineoplastic
/ administration & dosage
Antineoplastic Agents
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Bone Neoplasms
/ drug therapy
Bone Remodeling
/ drug effects
Breast Neoplasms
/ pathology
Capecitabine
/ administration & dosage
Case-Control Studies
Disease-Free Survival
Female
Humans
Neoplasm Metastasis
/ pathology
Radioisotopes
/ administration & dosage
Radium
/ administration & dosage
Safety
Treatment Outcome
Bone metastases
Bone turnover markers
Breast cancer
Capecitabine
Radium-223
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
15 Jan 2020
15 Jan 2020
Historique:
received:
05
02
2019
accepted:
09
08
2019
entrez:
17
1
2020
pubmed:
17
1
2020
medline:
20
11
2020
Statut:
epublish
Résumé
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. 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. 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. ISRCTN, ISRCTN92755158, Registered on 17 February 2016.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ISRCTN, ISRCTN92755158, Registered on 17 February 2016.
Identifiants
pubmed: 31941523
doi: 10.1186/s13063-019-3643-6
pii: 10.1186/s13063-019-3643-6
pmc: PMC6961242
doi:
Substances chimiques
Antimetabolites, Antineoplastic
0
Antineoplastic Agents
0
Radioisotopes
0
Capecitabine
6804DJ8Z9U
radium Ra 223 dichloride
RJ00KV3VTG
Radium
W90AYD6R3Q
Types de publication
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
89Références
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