Aging Mammary Stem Cells and Breast Cancer Prevention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02642094|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : March 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cancer of Breast||Drug: Rapamycin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Aging Mammary Stem Cells and Breast Cancer Prevention|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: The effect of short-term rapamycin treatment
Subjects will be given a low dose of rapamycin at 2 mg/day for 5-7 days of treatment. A surgical specimen will be taken 3-7 days after the last dose of rapamycin. The specimens will be evaluated for lesion size, nuclear grade, presence of necrosis in each patient's core biopsy and surgical specimens, as well as IHC (ImmunoHistoChemistry) for biomarkers including p16, COX2 (cyclooxygenase-2), and Ki-67. Specimens will also be tested for rapamycin treatment on the properties of mammary stem/progenitor cells as another biomarker for gauging the efficacy of rapamycin treatment.
Low dose of rapamycin at 2 mg/day for -5-7 days of treatment
Other Name: Sirolimus
- The effect of short-term rapamycin treatment on tumor grade and biomarkers associated with progression to invasive breast cancer [ Time Frame: Tissue samples will be collected 10 days after rapamycin dose for analysis. ]
- The effect of short-term rapamycin treatment on the presence or absence of necrosis [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
- The effect of short-term rapamycin treatment on luminal-to-basal epithelial ratio [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
- The effect of short-term rapamycin treatment on basal and luminal stem/progenitor cell frequency [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
- The effect of short-term rapamycin treatment on sphere regeneration frequency in serial passages [ Time Frame: A tissue sample will be collected 10 days after rapamycin dose for analysis. ]
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642094
|United States, Texas|
|University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||LuZhe Sun, PhD||University of Texas Health Science Center San Antonio, Co-PI|
|Principal Investigator:||Ismail Jatoi, MD||University of Texas Health Science Center San Antonio|
|Responsible Party:||LuZhe Sun, Co-Principal Investigator, The University of Texas Health Science Center at San Antonio|
|Other Study ID Numbers:||
1R01CA192564-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||December 30, 2015 Key Record Dates|
|Last Update Posted:||March 8, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
Neoplasms by Site
Physiological Effects of Drugs