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

NCT06246786 | Withdrawn Early Phase 1 FDA Drug

• 2 other identifiers: CTMS# 23-0094STUDY00000122
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Defective DNA repair; RAD51; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Ki67 Expression

  To evaluate changes in Ki67 expression after administration of CsA for 14-30 days in triple negative breast cancer tumors.

  6 weeks

Secondary Outcomes (2)

• Changes in g-H2Ax

  6 weeks

• Changes in apoptosis markers

  6 weeks

Study Arms (1)

Cyclosporin A

EXPERIMENTAL

Patients with newly diagnosed triple negative breast cancer with low or negative RAD51 (A protein coding gene that provides instructions for making a protein that is essential for repairing damaged DNA)

Drug: Cyclosporin A

Interventions

Cyclosporin A DRUG

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

Also known as: CsA

Cyclosporin A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants may be female or male who are 18 years old or older. Ability to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
• Previously untreated invasive breast cancer determined by a core needle biopsy.
• Prior, unrelated, breast cancer is allowed.
• Stage I-III breast cancer will be included that are Estrogen receptor and or progesterone receptor 0-10%, human epidermal growth factor receptor 2 (HER2) negative defined as per American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP guidelines). HER2 of 2+ on Immunohistochemistry (IHC) should have a ratio of less than 2.0 on fluorescence in situ hybridization (FISH) testing to be considered HER2 negative
• Patients must have low or negative RAD51 immunohistochemistry (defined as median \<5 foci per nucleus after measuring at least 200 cells)
• Patients must be able to take oral medications. Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug.
• Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of CsA.
• Women of childbearing potential and men should have an adequate mode of contraception to be eligible for this trial.
• Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing treatment.
• Patients must have a complete history and physical examination within 30 days prior to registration.
• Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.
• Tissue block of initial biopsy specimen is available.
• Patient may not be concurrently enrolled in another investigational drug treatment study.

You may not qualify if:

• Renal impairment defined as estimated glomerular filtration rate (EGFR) \<30
• Hepatic impairment as judged by clinical investigator or bilirubin \>2
• As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness, or social condition that would limit compliance with study requirements
• Known hypersensitivity to CsA
• Current use of calcium channel blockers, antifungals, azithromycin, clarithromycin, erythromycin, methylprednisolone, allopurinol, amiodarone, metoclopramide, bromocriptine, colchicine, oral contraceptives, nafcillin, rifampin, phenytoin, octreotide, phenobarbital, carbamazepine, St John's Wort, HIV protease inhibitors
• Inflammatory breast cancer
• Uncontrolled hypertension
• Pregnant or breast-feeding women. As there have been no well-controlled studies conducted with pregnant women to determine the effect of CsA on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug.
• Patients who will receive neoadjuvant chemotherapy for their triple negative breast cancer are not eligible for this clinical trial.

Sponsors & Collaborators

• Virginia G. Kaklamani: lead

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Virginia Kaklamani, MD, DSc

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Leader - Breast Oncology Program

Model Details: This will be a single arm, non-randomized, pre-surgical clinical trial

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 7, 2024
• Study Start: July 1, 2024
• Primary Completion: June 23, 2025
• Study Completion: June 23, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study closure and data have been analyzed.

Locations

US (1)