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. 2019 Sep;6(5):392-401.
doi: 10.1093/nop/npz003. Epub 2019 Feb 11.

Current state of clinical trials in breast cancer brain metastases

Jawad Fares  1 , Deepak Kanojia  1 , Alex Cordero  1 , Aida Rashidi  1 , Jason Miska  1 , Charles W Schwartz  1 , Solomiia Savchuk  1 , Atique U Ahmed  1 , Irina V Balyasnikova  1 , Massimo Cristofanilli  2 , William J Gradishar  2 , Maciej S Lesniak  1
Affiliations

Current state of clinical trials in breast cancer brain metastases

Jawad Fares et al. Neurooncol Pract. 2019 Sep.

Abstract

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.

Keywords: brain metastasis; breast cancer; clinical trials; therapy.

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Figures

Fig. 1
Fig. 1
Clinical trial selection process.
Fig. 2
Fig. 2
Distribution of trials (A) and patients (B) among phases.
Fig. 3
Fig. 3
Cumulative incidence of publications for primary clinical trial results.
See this image and copyright information in PMC

References

    1. Palmieri D, Smith QR, Lockman PR, et al. . Brain metastases of breast cancer. Breast Dis. 2006;26:139–147. - PubMed
    1. Weil RJ, Palmieri DC, Bronder JL, et al. . Breast cancer metastasis to the central nervous system. Am J Pathol. 2005;167(4):913–920. - PMC - PubMed
    1. Lin NU, Bellon JR, Winer EP. CNS metastases in breast cancer. J Clin Oncol. 2004;22(17):3608–3617. - PubMed
    1. Heitz F, Harter P, Lueck HJ, et al. . Triple-negative and HER2-overexpressing breast cancers exhibit an elevated risk and an earlier occurrence of cerebral metastases. Eur J Cancer. 2009;45(16):2792–2798. - PubMed
    1. Hicks DG, Short SM, Prescott NL, et al. . Breast cancers with brain metastases are more likely to be estrogen receptor negative, express the basal cytokeratin CK5/6, and overexpress HER2 or EGFR. Am J Surg Pathol. 2006;30(9):1097–1104. - PubMed