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| ID | Type | Description | Link |
|---|---|---|---|
| STUDY00000122 | Other Identifier | University of Texas Health Science Center at San Antonio |
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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.
Patients that are able to be in the study will be asked if they would like to be in the study on their first visit with their medical doctor. Lab work including a complete blood count and complete metabolic panel will be drawn at this time as part of their standard of care work-up. If patients choose to be in the study, they will then sign consent and then have the study drug dispensed on day 1 after a blood sample has being collected. No extra physician visit will be needed to join in the study. Patients will then take the study drug, CsA, until the day before surgery. Mastectomy (breast removal) or lumpectomy (lump removal) is the standard of care for early-stage breast cancer.
Surgery takes about three weeks to schedule, therefore we expect that patient's will take the study medication for between 14 and 30 days. There will be no delays in the standard of care surgery. There will be weekly visits and/or phone calls on Days 8, 15 and 21-30 to get feedback on any adverse effects and how the subject is dealing with changing the dosage, with any changes made to treatment as needed. The patients will stop taking the Cyclosporin (CsA) the day before surgery. Within two weeks after surgery, after the patient has been off drug, they will be questioned, and an assessment of adverse events will be done.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ki67 Expression | To evaluate changes in Ki67 expression after administration of CsA for 14-30 days in triple negative breast cancer tumors. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in g-H2Ax | To determine if CsA at a dose of 5mg/kg orally daily for 14- 30 days shows a change in g-H2Ax of triple negative breast cancer. | 6 weeks |
| Changes in apoptosis markers | To evaluate change in apoptosis markers by Tunnel assay after administration of CsA for 14-30 days in triple negative breast cancer tumors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Kaklamani, MD, DSc | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mays Cancer Center, UT Health San Antonio | San Antonio | Texas | 78229 | United States |
All collected deidentified individual participant data (IPD) that underlie results in a publication will be shared with other researchers upon request.
After study closure and data have been analyzed.
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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This will be a single arm, non-randomized, pre-surgical clinical trial
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| 6 weeks |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |