Broccoli Sprout Extract in Treating Patients With Breast Cancer

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.

Inclusion Criteria:

- Postmenopausal (no menstrual cycle in the past 12 months)

- Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial
malignancy, clinical stage I or II, ER positive or negative breast cancer, or ductal
carcinoma in situ (DCIS)

- No neoadjuvant endocrine therapy or chemotherapy within 12 months

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

- Willing to avoid cruciferous vegetable intake during the study period (2 weeks)

- Demonstrate the ability to swallow and retain oral medication

- Subject or legal representative must understand the investigational nature of this
study and sign an Independent Ethics Committee/Institutional Review Board approved
written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

- Prior invasive breast cancer, prior mastectomy or breast radiation within 12 months

- Current or recent use of reproductive hormone therapy, tamoxifen, aromatase inhibitor
or other estrogen inhibitors within the last 90 days, which may affect biomarkers

- Intolerance to broccoli/ITC-BSE taste

- Current ingestion of broccoli sprout extract, which may confound study results

- Current or recent treatment for any malignancy within the last one year, which may
affect biomarkers

- History of Crohn's disease, celiac sprue or other malabsorption syndrome which may
interfere with digestion and absorption of broccoli sprout extract

- Current diagnosis of Gastroesophageal Reflux Disease (GERD) with grade >3