WITHDRAWN

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

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Conditions

Triple Negative Breast CancerDNA Damage Repair DeficiencyDefective DNA repairRAD51Cyclosporine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-07-01
Study Completion:2025-06-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:WITHDRAWN

Study ID

NCT06246786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Previously untreated invasive breast cancer determined by a core needle biopsy.
  3. * Prior, unrelated, breast cancer is allowed.
  4. * 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
  5. * Patients must have low or negative RAD51 immunohistochemistry (defined as median \<5 foci per nucleus after measuring at least 200 cells)
  6. * 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.
  7. * 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.
  8. * Women of childbearing potential and men should have an adequate mode of contraception to be eligible for this trial.
  9. * Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing treatment.
  10. * Patients must have a complete history and physical examination within 30 days prior to registration.
  11. * Patients must have a performance status of Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2.
  12. * Tissue block of initial biopsy specimen is available.
  13. * Patient may not be concurrently enrolled in another investigational drug treatment study.
  1. * Renal impairment defined as estimated glomerular filtration rate (EGFR) \<30
  2. * Hepatic impairment as judged by clinical investigator or bilirubin \>2
  3. * As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness, or social condition that would limit compliance with study requirements
  4. * Known hypersensitivity to CsA
  5. * 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
  6. * Inflammatory breast cancer
  7. * Uncontrolled hypertension
  8. * 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.
  9. * Patients who will receive neoadjuvant chemotherapy for their triple negative breast cancer are not eligible for this clinical trial.

Contacts and Locations

Principal Investigator

Virginia Kaklamani, MD, DSc
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio

Study Locations (Sites)

Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Virginia G. Kaklamani

  • Virginia Kaklamani, MD, DSc, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2025-06-23

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2025-06-23

Terms related to this study

Keywords Provided by Researchers

  • Defective DNA repair
  • RAD51
  • Cyclosporine

Additional Relevant MeSH Terms

  • Triple Negative Breast Cancer
  • DNA Damage Repair Deficiency