This randomized pilot trial studies broccoli sprout extract in treating patients with breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers. Studying samples of tissue from patients receiving broccoli sprout extract may help determine if it can enter breast tumor cells and how it affects certain biomarkers.
PRIMARY OBJECTIVES: I. To determine whether isothiocyanate-rich broccoli sprout extract (ITC-BSE) modifies biomarkers in breast tumor cells. II. To determine whether the intervention alters proliferative and apoptotic markers (Ki-67 and cleaved caspase-3). III. To determine whether the intervention down-regulates the expression of estrogen receptor (ER) including both ERalpha and ERbeta. IV. To determine whether the intervention induces NAD(P)H dehydrogenase (quinone) 1 (NQO1) expression. SECONDARY OBJECTIVES: I. To determine tolerability of ITC-BSE and compliance in breast cancer patients. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive broccoli sprout extract orally (PO) once daily (QD) on days 1-14 immediately prior to surgery. ARM II: Patients receive placebo PO QD on days 1-14 immediately prior to surgery. After completion of study treatment, patients are followed up at 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
30
Roswell Park Cancer Institute
Buffalo, New York, United States
Changes in apoptosis (cleaved caspase 3)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Time frame: Baseline to up to 14 days
Changes in cell proliferation (Ki-67)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Time frame: Baseline to up to 14 days
Changes in estrogen receptor expression (ER alpha and ER beta)
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Time frame: Baseline to up to 14 days
Changes in NQO1 expression
Appropriate transformation (such log transformation) will be used to achieve normality of the data. Results will be given as the back-transformed geometric means and 95% confidence intervals in order to preserve the units of measurement. Change in immunohistochemistry measures will be calculated for each individual and compared between treatment and placebo groups by use of independent samples t-test. If the normality could not be reached by transformation, Wilcoxon rank-sum test will be used, which considers both the direction and the magnitude of changes.
Time frame: Baseline to up to 14 days
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