Broccoli Sprout Extract in Treating Patients With Breast Cancer

NCT01753908 | Completed Early Phase 1 DMC

• 4 other identifiers: I 211911NCI-2012-01770K07CA148888P30CA016056
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline to up to 14 days

Study Arms (2)

Arm I (broccoli sprout extract)

EXPERIMENTAL

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

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

Arm II (placebo)

PLACEBO COMPARATOR

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

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo

Interventions

Broccoli Sprout Extract DRUG

Given PO

Arm I (broccoli sprout extract)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (broccoli sprout extract); Arm II (placebo)

Pharmacological Study OTHER

Urinary ITCs and metabolites measured

Arm I (broccoli sprout extract); Arm II (placebo)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Carcinoma, Ductal, Breast; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Breast Carcinoma In Situ; Carcinoma in Situ

Study Officials

• Jessica Young

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2012
• First Posted: December 20, 2012
• Study Start: May 21, 2013
• Primary Completion: July 23, 2018
• Study Completion: August 23, 2018
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

US (1)