NCT01753908

Broccoli Sprout Extract in Treating Patients With Breast Cancer

A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Broccoli Sprout Extract	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Urinary ITCs and metabolites measured
OTHER	Placebo	Given PO

Timeline

• Start date: 2013-05-21
• Primary completion: 2018-07-23
• Completion: 2018-08-23
• First posted: 2012-12-20
• Last updated: 2019-10-31

Locations

1 site across 1 country: United States