Breast Cancer Clinical Trial
Official title:
Sulforaphane: A Dietary Histone Deacetylase (HDAC) Inhibitor in Ductal Carcinoma in Situ (DCIS)
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.
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