Broccoli Sprout Extract in Treating Patients With Breast Cancer

Early Phase 1

Completed

• Conditions: Ductal Breast Carcinoma; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Ductal Breast Carcinoma In Situ; Estrogen Receptor Negative; Estrogen Receptor Positive; Invasive Breast Carcinoma; Lobular Breast Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis; Drug: Broccoli Sprout Extract; Other: Pharmacological Study; Other: Placebo

• Registration Number: NCT01753908
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-20
• Study Start: 2013-05-21
• Primary Completion: 2018-07-23
• Study Completion: 2018-08-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (placebo)	Placebo	Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
Arm II (placebo)	Laboratory Biomarker Analysis	Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
Arm II (placebo)	Pharmacological Study	Patients receive placebo PO QD on days 1-14 immediately prior to surgery.
Arm I (broccoli sprout extract)	Broccoli Sprout Extract	Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
Arm I (broccoli sprout extract)	Laboratory Biomarker Analysis	Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.
Arm I (broccoli sprout extract)	Pharmacological Study	Patients receive broccoli sprout extract PO QD on days 1-14 immediately prior to surgery.

Primary Outcome Measures

Name	Time	Method
Changes in apoptosis (cleaved caspase 3)	Baseline to up to 14 days	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.
Changes in estrogen receptor expression (ER alpha and ER beta)	Baseline to up to 14 days	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.
Changes in cell proliferation (Ki-67)	Baseline to up to 14 days	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.
Changes in NQO1 expression	Baseline to up to 14 days	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States