Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
Broccoli Sprout Extract in Treating Women Who Have Had a Mammogram and Breast Biopsy
RATIONALE: Broccoli sprout extract supplements may slow the growth of tumor cells or abnormal
 cells and may be an effective treatment for ductal carcinoma in situ and/or atypical ductal
 hyperplasia.

 PURPOSE: This randomized phase II trial is studying how well broccoli sprout extract works in
 treating women with a diagnosis of breast cancer, ductal carcinoma in situ and/or atypical
 ductal hyperplasia.
OBJECTIVES:

 -  To determine the correlation between supplemental sulforaphane (broccoli sprout extract)
 dose and concentrations of sulforaphane and its metabolites in blood and urine samples
 from women positive for cancer, ductal carcinoma in situ and/or atypical ductal
 hyperplasia.

 -  To determine the effect of this supplement on biomarkers of prognosis in these patients.

 -  To determine the effect of this supplement on HDAC inhibition in peripheral blood cell
 and normal and cancerous breast tissue samples from these patients.

 OUTLINE: Patients are randomized to 1 of 2 treatment arms.

 -  Sulforaphane Supplement: Patients receive oral broccoli sprout extract supplementation
 three times daily for 2-8 weeks in the absence of unacceptable toxicity.

 -  Placebo: Patients receive oral placebo supplementation three times daily for 2-8 weeks
 in the absence of unacceptable toxicity.

 Blood and urine samples are collected at baseline and after completion of study treatment for
 laboratory biomarker studies. Patients scheduled to undergo surgery (mastectomy or
 lumpectomy) also undergo breast tissue sample collection at baseline and at the time of
 surgery. Samples are analyzed for sulforaphane metabolism (isothiocyanate levels), HDAC
 activity (acetylated histone expression), cell proliferation (Ki-67 index by IHC), and
 apoptosis (TUNEL assay).

 Patients complete questionnaires at baseline and periodically during study about their
 dietary history, family history, cruciferous vegetable intake, adverse events, and dietary
 and medication changes.

 After completion of study therapy, patients are followed at/around 30 days.
INCLUSION CRITERIA:

 -  Diagnostic mammogram

 -  English speaking

 EXCLUSION CRITERIA:

 -  Pregnancy (as determined by urine human chorionic gonadotropin (hCG) test)

 -  No biopsy referral after diagnostic mammogram

 -  Patient reported breast feeding

 -  Significant active medical illness which in the opinion of the investigator would
 preclude protocol treatment

 -  History of or active liver disease or baseline total bilirubin greater than
 institutional upper limit of normal

 -  Patient reported allergy or sensitivity to cruciferous vegetables

 -  Use of oral antibiotics within three months prior to randomization

 -  Oral steroid therapy at enrollment

 -  Current therapy with valproate acid or SAHA

 -  Current use of nutrient supplements or herbal remedies containing sulforaphane and
 unwillingness or inability to quit 72 hours prior to randomization and for the
 duration of the trial

 -  Radiation for currently-diagnosed disease prior to or during study supplementation

 -  Chemotherapy for currently-diagnosed disease prior to or during study supplementation