Aging Mammary Stem Cells and Breast Cancer Prevention
Lay Description
To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens
Category
- Cancers and Other Neoplasms
- Breast
- IRB Number
- 20150556HU
- NCT Number
- NCT02642094
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
- Women diagnosed with DCIS/LCIS, Atypical lobular hyperplasia (ALH) or ADH lesions detected by pathology
- Women scheduled for mastectomy or lumpectomy after DCIS/LCIS, ALH or ADH diagnosis
- Women consented to the UT Health Cancer Center MD Anderson Cancer Center tissue biorepository (HSC20070684H)
- Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
- Women of child-bearing potential must have a negative serum pregnancy test at time of enrollment.
- Patients must be able to swallow and retain oral medication.
- All patients must have given signed informed consent prior to registration on study.
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Patients must have normal organ and marrow function as defined below:
- Leukocytes ≥ 3,000/uL
- Absolute neutrophil count ≥ 1,500/uL
- Platelets ≥ 100,000/uL
- AST ≤ 2.5 X ULN
- ALT ≤ 2.5 X ULN
- Total bili ≤ 1.5 X ULN or Direct bili ≤ 1 X ULN
Exclusion Criteria
- Women who are pregnant.
- Women who are receiving any other concomitant treatment for their DCIS/LCIS, ALH or ADH
- Women who are taking rapamycin for another diagnosis.
- Women with an allergy to rapamycin or its derivatives.
- Active infection requiring systemic therapy.
- Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
- Immunocompromised subjects, including patients with human immunodeficiency virus
- Women currently taking strong CYP3A4 inducers or inhibitors. Drugs that cannot be coadministered with rapamycin include but are not limited to: Calcium channel blockers: nicardipine, Antifungal agents: clotrimazole, fluconazole, Antibiotics: troleandomycin, Gastrointestinal prokinetic agents: cisapride, metoclopramide, Other drugs: bromocriptine, cimetidine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir), Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Antibiotics: rifapentine. The research team can provide a full list of these medications.
-
Patients with any of the following conditions or complications are NOT eligible for participation:
- GI tract disease resulting in an inability to take oral medication
- Malabsorption syndrome
- Require IV alimentation
- History of prior surgical procedures affecting absorption
- Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
Study Design
Arm Groups
Study Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Ismail Jatoi
(210) 567-5759
jatoi@uthscsa.edu
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Staff
regaffstaff@uthscsa.edu
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Principal Investigator
Ismail Jatoi