Current state of clinical trials in breast cancer brain metastases

Jawad Fares, Deepak Kanojia, Alex Cordero, Aida Rashidi, Jason Michael Miska, Charles W. Schwartz, Solomiia Savchuk, Atique Uddin Ahmed, Irina V Balyasnikova, Massimo Cristofanilli, William J Gradishar, Maciej S Lesniak*

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)392-401
Number of pages10
JournalNeuro-Oncology Practice
Volume6
Issue number5
DOIs
StatePublished - Sep 20 2019

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Brain Neoplasms
Clinical Trials
Breast Neoplasms
Neoplasm Metastasis
Patient Selection
Therapeutics
Sample Size
Publications
Research

Keywords

  • brain metastasis
  • breast cancer
  • clinical trials
  • therapy

ASJC Scopus subject areas

  • Medicine (miscellaneous)

Cite this

Fares, Jawad ; Kanojia, Deepak ; Cordero, Alex ; Rashidi, Aida ; Miska, Jason Michael ; Schwartz, Charles W. ; Savchuk, Solomiia ; Ahmed, Atique Uddin ; Balyasnikova, Irina V ; Cristofanilli, Massimo ; Gradishar, William J ; Lesniak, Maciej S. / Current state of clinical trials in breast cancer brain metastases. In: Neuro-Oncology Practice. 2019 ; Vol. 6, No. 5. pp. 392-401.
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Current state of clinical trials in breast cancer brain metastases. / Fares, Jawad; Kanojia, Deepak; Cordero, Alex; Rashidi, Aida; Miska, Jason Michael; Schwartz, Charles W.; Savchuk, Solomiia; Ahmed, Atique Uddin; Balyasnikova, Irina V; Cristofanilli, Massimo; Gradishar, William J; Lesniak, Maciej S.

In: Neuro-Oncology Practice, Vol. 6, No. 5, 20.09.2019, p. 392-401.

Research output: Contribution to journalArticle

TY - JOUR

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AU - Fares, Jawad

AU - Kanojia, Deepak

AU - Cordero, Alex

AU - Rashidi, Aida

AU - Miska, Jason Michael

AU - Schwartz, Charles W.

AU - Savchuk, Solomiia

AU - Ahmed, Atique Uddin

AU - Balyasnikova, Irina V

AU - Cristofanilli, Massimo

AU - Gradishar, William J

AU - Lesniak, Maciej S

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Fares J, Kanojia D, Cordero A, Rashidi A, Miska JM, Schwartz CW et al. Current state of clinical trials in breast cancer brain metastases. Neuro-Oncology Practice. 2019 Sep 20;6(5):392-401. https://doi.org/10.1093/nop/npz003