Breast/Cyclosporin A/TNBC (Triple Negative Breast Cancer)
NCT06246786 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2025-07-16
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.
Conditions
- Triple Negative Breast Cancer
- DNA Damage Repair Deficiency
Interventions
- 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.
Sponsors & Collaborators
-
Virginia G. Kaklamani
lead OTHER
Principal Investigators
-
Virginia Kaklamani, MD, DSc · The University of Texas Health Science Center at San Antonio
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2025-06-23
- Completion
- 2025-06-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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