NCT06246786

Breast/Cyclosporin A/TNBC (Triple Negative Breast Cancer)

A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Cyclosporin A on Triple Negative Breast Cancer With Defective DNA Repair

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Virginia G. Kaklamani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly diagnosed triple negative breast cancer with high g-H2Ax (gamma H2AX antibodies) comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.

Detailed description

Patients that are able to be in the study will be asked if they would like to be in the study on their first visit with their medical doctor. Lab work including a complete blood count and complete metabolic panel will be drawn at this time as part of their standard of care work-up. If patients choose to be in the study, they will then sign consent and then have the study drug dispensed on day 1 after a blood sample has being collected. No extra physician visit will be needed to join in the study. Patients will then take the study drug, CsA, until the day before surgery. Mastectomy (breast removal) or lumpectomy (lump removal) is the standard of care for early-stage breast cancer. Surgery takes about three weeks to schedule, therefore we expect that patient's will take the study medication for between 14 and 30 days. There will be no delays in the standard of care surgery. There will be weekly visits and/or phone calls on Days 8, 15 and 21-30 to get feedback on any adverse effects and how the subject is dealing with changing the dosage, with any changes made to treatment as needed. The patients will stop taking the Cyclosporin (CsA) the day before surgery. Within two weeks after surgery, after the patient has been off drug, they will be questioned, and an assessment of adverse events will be done.

Conditions

• Triple Negative Breast Cancer
• DNA Damage Repair Deficiency

Interventions

Type	Name	Description
DRUG	Cyclosporin A	Patients will begin treatment at 5mg/kg/day in 2 divided doses until the day before surgery at which time they will stop CsA.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-23
• Completion: 2025-06-23
• First posted: 2024-02-07
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study