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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02642094.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. Toxicity.
II. Surgical complications.
OUTLINE:
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.
Lead OrganizationCancer Therapy and Research Center at The UT Health Science Center at San Antonio
Principal InvestigatorIsmail Jatoi