Broccoli Sprout Extract in Treating Patients With Breast Cancer

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Early Phase 1

Conditions: Ductal Breast Carcinoma; Stage IB Breast Cancer; Invasive Breast Carcinoma; Postmenopausal; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Estrogen Receptor Negative; Stage IA Breast Cancer; Estrogen Receptor Positive; Lobular Breast Carcinoma; Ductal Breast Carcinoma In Situ

Treatments: Other: Placebo; Other: Laboratory Biomarker Analysis; Drug: Broccoli Sprout Extract; Other: Pharmacological Study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01753908

P30CA016056 (U.S. NIH Grant/Contract)

I 211911 (Other Identifier)

NCI-2012-01770 (Registry Identifier)

K07CA148888 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Arm I (broccoli sprout extract)

Experimental group

Description:

Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

Treatment:

Drug: Broccoli Sprout Extract

Other: Pharmacological Study

Other: Laboratory Biomarker Analysis

Arm II (placebo)

Placebo Comparator group

Description:

Patients receive placebo PO QD on days 1-14 immediately prior to surgery.

Treatment:

Other: Pharmacological Study

Other: Laboratory Biomarker Analysis

Other: Placebo