Aging Mammary Stem Cells and Breast Cancer Prevention
Condition: Cancer of Breast
MeSH terms: Breast Neoplasms
Intervention: Rapamycin
Intervention description: Low dose of rapamycin at 2 mg/day for -5-7 days of treatment
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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

Eligibility criteria:

        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.

          -  Patients must have normal organ and marrow function as defined below:

               1. Leukocytes ≥ 3,000/uL

               2. Absolute neutrophil count ≥ 1,500/uL

               3. Platelets ≥ 100,000/uL

               4. AST ≤ 2.5 X ULN

               5. ALT ≤ 2.5 X ULN

               6. 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:

               1. GI tract disease resulting in an inability to take oral medication

               2. Malabsorption syndrome

               3. Require IV alimentation

               4. History of prior surgical procedures affecting absorption

               5. Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)