Using Cyclosporin A for treating 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
This study is testing if the drug Cyclosporin A can help women with newly diagnosed triple negative breast cancer by looking at changes in their cancer markers before surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06246786 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a single-arm, non-randomized, pre-surgical intervention for women with newly diagnosed triple negative breast cancer who exhibit high levels of gamma H2AX antibodies. Participants will receive the study drug, Cyclosporin A, for a duration of 14 to 30 days prior to their scheduled surgery, with regular monitoring for adverse effects. The trial aims to compare biomarker changes from initial diagnostic biopsies to surgical pathology specimens. Patients will not need additional visits beyond their standard care to participate in the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed invasive triple negative breast cancer that meets specific biomarker criteria.
Not a fit: Patients with breast cancer that is not triple negative or those who have received prior treatment for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with triple negative breast cancer by enhancing the effectiveness of pre-surgical therapy.
How similar studies have performed: While there have been studies exploring the use of Cyclosporin A in cancer treatment, this specific approach in triple negative breast cancer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
San Antonio, Texas
- Mays Cancer Center, UT Health San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Virginia Kaklamani, MD, DSc — The University of Texas Health Science Center at San Antonio
- Study coordinator: Epp Goodwin
- Email: goodwine@uthscsa.edu
- Phone: 210-450-5798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.