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Current state of clinical trials in breast cancer brain metastases
Jawad Fares1, Deepak Kanojia1, Alex Cordero1
1Department of Neurological Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
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:
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:
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:
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.
Insights
Clinical trials for breast cancer brain metastases (BCBM) face challenges including low accrual and few published results. Optimizing trial design is crucial for developing effective BCBM therapies.
Area of Science:
- Neuro-oncology
- Medical oncology
- Clinical trial research
Background:
- Breast cancer brain metastases (BCBM) represent a significant challenge in neuro-oncology.
- There is a critical need for more effective therapies to treat BCBM.
- This study analyzes clinical trials to identify limitations in BCBM therapy development.
Purpose of the Study:
- To explore existing clinical trials for BCBM.
- To identify shortcomings in the development of new BCBM therapies.
- To suggest areas for improvement in future BCBM research.
Main Methods:
- A comprehensive search of ClinicalTrials.gov was conducted on July 9, 2018.
- Interventional and therapeutic clinical trials for BCBM were included, irrespective of date or location.
- Data on trial characteristics, interventions, and outcomes were collected and analyzed.
Main Results:
- Fifty-three trials met the inclusion criteria, with a median duration of 3-6 years.
- Most trials were in early phases (I-II), with a significant portion of patients in phase III.
- Low completion rates (33%), early terminations (23% due to poor enrollment), and limited publication of results (13% overall) were observed.
Conclusions:
- Key challenges in BCBM research include a low number of trials, insufficient patient accrual, limited diversity, and a scarcity of published results.
- There is a need to optimize clinical trial design and execution for BCBM.
- Enhancing BCBM trial optimization is essential for advancing effective treatment strategies.
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