Current state of clinical trials in breast cancer brain metastases.
brain metastasis
breast cancer
clinical trials
therapy
Journal
Neuro-oncology practice
ISSN: 2054-2577
Titre abrégé: Neurooncol Pract
Pays: England
ID NLM: 101640528
Informations de publication
Date de publication:
Sep 2019
Sep 2019
Historique:
received:
08
10
2018
revised:
05
12
2018
accepted:
10
01
2019
entrez:
27
9
2019
pubmed:
27
9
2019
medline:
27
9
2019
Statut:
ppublish
Résumé
Breast cancer brain metastases (BCBM) are the final frontier in neuro-oncology for which more efficacious therapies are required. In this work, we explore clinical trials in BCBM, and determine the shortcomings in the development of new BCBM therapies to shed light on potential areas for enhancement. On July 9, 2018, we searched ClinicalTrials.gov for all interventional and therapeutic clinical trials involving BCBM, without limiting for date or location. Information on trial characteristics, including phase, status, start and end dates, study design, primary endpoints, selection criteria, sample size, experimental interventions, results, and publications were collected and analyzed. Fifty-three trials fulfilled the selection criteria. Median trial duration across phases ranged between 3 and 6 years. More than half of the trials were conducted in the United States. Although 94% of the trials were in early phases (I-II), 20% of patients were in phase III trials. Two phase III trials were anteceded by phase II trials that were non-randomized; one reported positive results. Approximately one-third of the trials were completed, whereas 23% of trials were terminated early; mostly due to inadequate enrollment. Only 13% of all trials and 22% of completed trials had published results directly linked to their primary outcomes. The low number of trials and accrual numbers, the lack of diversity, and the scarcity of published results represent the main troubles in clinical BCBM research. Optimization of BCBM trials is necessary to achieve effective therapies.
Sections du résumé
BACKGROUND
BACKGROUND
Breast cancer brain metastases (BCBM) are the final frontier in neuro-oncology for which more efficacious therapies are required. In this work, we explore clinical trials in BCBM, and determine the shortcomings in the development of new BCBM therapies to shed light on potential areas for enhancement.
METHODS
METHODS
On July 9, 2018, we searched ClinicalTrials.gov for all interventional and therapeutic clinical trials involving BCBM, without limiting for date or location. Information on trial characteristics, including phase, status, start and end dates, study design, primary endpoints, selection criteria, sample size, experimental interventions, results, and publications were collected and analyzed.
RESULTS
RESULTS
Fifty-three trials fulfilled the selection criteria. Median trial duration across phases ranged between 3 and 6 years. More than half of the trials were conducted in the United States. Although 94% of the trials were in early phases (I-II), 20% of patients were in phase III trials. Two phase III trials were anteceded by phase II trials that were non-randomized; one reported positive results. Approximately one-third of the trials were completed, whereas 23% of trials were terminated early; mostly due to inadequate enrollment. Only 13% of all trials and 22% of completed trials had published results directly linked to their primary outcomes.
CONCLUSIONS
CONCLUSIONS
The low number of trials and accrual numbers, the lack of diversity, and the scarcity of published results represent the main troubles in clinical BCBM research. Optimization of BCBM trials is necessary to achieve effective therapies.
Identifiants
pubmed: 31555454
doi: 10.1093/nop/npz003
pii: npz003
pmc: PMC6753353
doi:
Types de publication
Journal Article
Langues
eng
Pagination
392-401Subventions
Organisme : NINDS NIH HHS
ID : R01 NS087990
Pays : United States
Organisme : NCI NIH HHS
ID : R35 CA197725
Pays : United States
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