Aging Mammary Stem Cells and Breast Cancer Prevention

Stopped early · Phase 2

Conditions studied: Cancer of Breast

In brief

To examine whether rapamycin can reduce malignant markers and aberrant mammary stem/progenitor cells (MaSCs) number in surgical specimens

Key facts

Study ID

NCT02642094

Run by

LuZhe Sun

People needed

58

Starts

2016-07-01

Expected to finish

2022-05-01

Last updated by the study team

2023-12-05

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Texas Health Science Center San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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