NCT03796273

Ketoconazole Before Surgery in Treating Patients With Recurrent Glioma or Breast Cancer Brain Metastases

Terminated EARLY_PHASE1 Last updated 20 March 2026

What this trial tests

EARLY_PHASE1 trial testing Best Practice in Anatomic Stage IV Breast Cancer AJCC v8 in 15 participants. Terminated before completion.

Timeline

13 March 2019

Primary endpoint
23 October 2022

23 October 2022

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	13 March 2019
Primary completion	23 October 2022
Estimated completion	23 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Best Practice
• Ketoconazole (ketoconazole) — full drug profile →

Conditions studied

• Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
• Astrocytoma — all drugs for Astrocytoma →
• Breast Carcinoma Metastatic in the Brain — all drugs for Breast Carcinoma Metastatic in the Brain →
• Glioma — all drugs for Glioma →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Astrocytoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial studies the side effects and how well ketoconazole works before surgery in treating patients with glioma that has come back or breast cancer that has spread to the brain. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exosome Processing and Characterization Approaches for Research and Technology Development.
   Lai JJ, Chau ZL, Chen SY, Hill JJ, et al · · 2022 · cited 385× · PMID 35332686 · DOI 10.1002/advs.202103222
2. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
   Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006
3. Emerging treatment strategies for breast cancer brain metastasis: from translational therapeutics to real-world experience.
   Ren D, Cheng H, Wang X, Vishnoi M, et al · · 2020 · cited 19× · PMID 32655700 · DOI 10.1177/1758835920936151
4. Current Opportunities for Targeting Dysregulated Neurodevelopmental Signaling Pathways in Glioblastoma.
   Drakulic D, Schwirtlich M, Petrovic I, Mojsin M, et al · · 2022 · cited 17× · PMID 36010607 · DOI 10.3390/cells11162530
5. Navigating the Blood-Brain Barrier: Challenges and Therapeutic Strategies in Breast Cancer Brain Metastases.
   Terceiro LEL, Ikeogu NM, Lima MF, Edechi CA, et al · · 2023 · cited 14× · PMID 37569410 · DOI 10.3390/ijms241512034
6. An FDA-Approved Antifungal, Ketoconazole, and Its Novel Derivative Suppress tGLI1-Mediated Breast Cancer Brain Metastasis by Inhibiting the DNA-Binding Activity of Brain Metastasis-Promoting Transcription Factor tGLI1.
   Doheny D, Manore S, Sirkisoon SR, Zhu D, et al · · 2022 · cited 11× · PMID 36077791 · DOI 10.3390/cancers14174256
7. Path to Clonal Theranostics in Luminal Breast Cancers.
   Hajjaji N, Aboulouard S, Cardon T, Bertin D, et al · · 2021 · cited 7× · PMID 35096604 · DOI 10.3389/fonc.2021.802177
8. NFX1-123: A potential therapeutic target in cervical cancer.
   Chintala S, Dankoski MA, Anbarasu A, Ramaiah S, et al · · 2023 · cited 4× · PMID 37288708 · DOI 10.1002/jmv.28856