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Sirolimus in Preventing Invasive Breast Cancer in Patients with Ductal Carcinoma In Situ, Lobular Carcinoma In Situ, Atypical Lobular Hyperplasia, or Atypical Ductal Hyperplasia

Trial Status: Closed to Accrual and Intervention

This phase II trial studies how well sirolimus works in preventing invasive breast cancer in patients with breast cancer confined to the mammary ducts or lobules of the breast. Sirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Inclusion Criteria

  • 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 follicle stimulating hormone (FSH) and estradiol local labs
  • Women diagnosed with DCIS, LCIS, ALH or ADH lesions detected by pathology
  • Women scheduled for mastectomy or lumpectomy after DCIS, LCIS, ALH or ADH diagnosis
  • 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
  • Leukocytes >= 3,000/uL
  • Absolute neutrophil count >= 1,500/uL
  • Platelets >= 100,000/uL
  • Aspartate aminotransferase (AST) =< 2.5 x upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) =< 2.5 x ULN
  • Total bilirubin (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 cytochrome P450 family 3 subfamily A member 4 (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, rifapentine, gastrointestinal prokinetic agents: cisapride, metoclopramide, other drugs: bromocriptine, cimetidine, danazol, human immunodeficiency virus (HIV)-protease inhibitors (e.g., ritonavir, indinavir), anticonvulsants: carbamazepine, phenobarbital, phenytoin
  • Patients with any of the following conditions or complications are NOT eligible for participation: * Gastrointestinal (GI) tract disease resulting in an inability to take oral medication * Malabsorption syndrome * Require intravenous (IV) alimentation * History of prior surgical procedures affecting absorption * Uncontrolled inflammatory GI disease (e.g., Crohn’s, ulcerative colitis)


San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Contact: Ismail Jatoi
Phone: 210-355-4604


I. Reduction of mammary stem/progenitor cells (MaSC) in ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), atypical lobular hyperplasia (ALH) or atypical ductal hyperplasia (ADH) in patients receiving sirolimus (rapamycin).

II. Reduction of malignant markers in DCIS, LCIS, ALH or ADH in patients receiving rapamycin.


I. Toxicity.

II. Surgical complications.


Patients receive sirolimus orally (PO) once daily (QD) for 5-7 days. Beginning 3-7 days after the last dose of sirolimus, patients undergo surgery.

After completion of study treatment, patients are followed up at 3 months.

Trial Phase Phase II

Trial Type Prevention

Lead Organization
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio

Principal Investigator
Ismail Jatoi

  • Primary ID CTMS# 15-2096
  • Secondary IDs NCI-2016-01112, HSC20150556H
  • ID NCT02642094