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

Launched by VIRGINIA G. KAKLAMANI · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for women and men with triple negative breast cancer, specifically those whose cancer shows signs of DNA damage repair deficiency. The study involves giving participants a medication called Cyclosporin A (CsA) before surgery to see how it affects certain biological markers related to their cancer. The goal is to better understand how this treatment works and if it can help improve outcomes for patients with this type of breast cancer.

To be eligible for the trial, participants must be at least 18 years old and have been diagnosed with invasive triple negative breast cancer that has not been treated before. They should also have good overall health and be able to take medications orally. The study requires a core needle biopsy for diagnosis, and participants must be planning for surgery to remove the tumor. Throughout the trial, patients will have regular check-ups and tests to monitor their health and the effects of the treatment. It’s important to note that this trial is currently recruiting participants, and those interested should consult with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility 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.