Ketoconazole for Breast Cancer

Phase-Based Progress Estimates
Wake Forest University Health Sciences, Winston-Salem, NCBreast Cancer+7 MoreKetoconazole - Drug
All Sexes
What conditions do you have?

Study Summary

This trial is testing ketoconazole as a possible treatment for brain tumors. Ketoconazole is an antifungal drug that may be able to block a protein, tGLI1 and may help to treat brain tumors.

Eligible Conditions
  • Breast Cancer Metastatic to the Brain
  • Astrocytoma
  • Oligodendroglioma
  • Stage IV Breast Cancer
  • Brain Tumor
  • Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Up to 30 days after surgery

Day 30
Changes in tGLI1 signaling pathway
Day 30
Overall survival (OS)
Day 30
Blood brain penetrance of ketoconazole in serum relative to enhancing brain tissue
Incidence of adverse events (AEs)
Serum ketoconazole concentrations in Cerebrospinal Fluid (CSF)
Serum ketoconazole concentrations in enhancing brain tissue
Serum ketoconzcole concentrations in unenhancing brain tissue
tGLI1 activation signature 8 (t-GAS 8)
tGLI1 pathway activation

Trial Safety

Trial Design

2 Treatment Groups

Arm II (standard surgery)
1 of 2
Arm I (ketoconazole)
1 of 2

Active Control

Experimental Treatment

19 Total Participants · 2 Treatment Groups

Primary Treatment: Ketoconazole · No Placebo Group · Phase < 1

Arm I (ketoconazole)Experimental Group · 2 Interventions: Ketoconazole, Best Practice · Intervention Types: Drug, Other
Arm II (standard surgery)
ActiveComparator Group · 1 Intervention: Best Practice · Intervention Types: Other
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after surgery

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,149 Previous Clinical Trials
1,141,017 Total Patients Enrolled
31 Trials studying Breast Cancer
4,977 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,163,581 Total Patients Enrolled
928 Trials studying Breast Cancer
1,536,849 Patients Enrolled for Breast Cancer
Roy StrowdPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
77 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

To what extent has Ketoconazole been tested in other medical trials?

"Presently, 10 research trials for Ketoconazole are ongoing. Of these initiatives, one is in its advanced Phase 3 phase. While the majority of studies occur in Rochester, Minnesota, there are 28 total sites conducting experiments with this treatment." - Anonymous Online Contributor

Unverified Answer

Is there an ongoing recruitment process for participants in this experiment?

"Affirmative. documents this clinical trial as currently recruiting participants, which began on March 13th 2019 and was most recently modified on October 6th 2022. A total of 19 patients are needed to complete the study at one medical site." - Anonymous Online Contributor

Unverified Answer

Has this investigation ever been conducted before?

"Presently, 10 clinical trials involving Ketoconazole are taking place in 23 cities spread across 3 nations. The initial trial for this medication was launched by Sanofi back in 2004 and featured 20 patients; the drug approval process concluded at that time. Since then, 121 additional studies have been completed." - Anonymous Online Contributor

Unverified Answer

What medical ailments does Ketoconazole typically address?

"Ketoconazole is the primary drug used to fight coccidioidomycosis, although it can be helpful in warding off other illnesses like paracoccidioidomycosis and tinea corporis caused by trichophyton mentagrophytes. It may also provide assistance with chromomycosis." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment rate for participants in this trial?

"Affirmative, the clinical data posted on demonstrates that this medical investigation is actively searching for study participants. Initially posted on March 13th 2019 and most recently revised October 6th of 2022, 19 patients are needed to take part at 1 location." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.