Trial record 1 of 1 for:    NCT01753908
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Broccoli Sprout Extract in Treating Patients With Estrogen Receptor-Positive Breast Cancer

This study is currently recruiting participants.
Verified February 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01753908
First received: December 10, 2012
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

This randomized pilot trial studies broccoli sprout extract in treating patients with estrogen receptor-positive breast cancer. Broccoli sprout extract contains ingredients that may prevent or slow the growth of certain cancers.


Condition Intervention
Estrogen Receptor-positive Breast Cancer
Invasive Ductal Breast Carcinoma
Invasive Lobular Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Drug: broccoli sprout extract
Other: placebo
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Pilot Study of Broccoli Sprout Extract in Patients With Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Changes in cell proliferation (Ki-67) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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 apoptosis (cleaved caspase 3) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (broccoli sprout extract)
Patients receive broccoli sprout extract PO QD on days 1-14.
Drug: broccoli sprout extract
Given PO
Other: laboratory biomarker analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-14.
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies

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).

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.

ARM II: Patients receive placebo PO QD on days 1-14.

After completion of study treatment, patients are followed up at 30 days.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal (no menstrual cycle in the past 12 months), because menstrual cycle affects baseline expression of biomarkers such as Ki-67
  • Diagnosed with incident, primary, invasive, ductal or lobular, or other epithelial malignancy, clinical stage I or II, ER positive breast cancer
  • No neoadjuvant endocrine therapy or chemotherapy
  • No prior chemotherapy
  • 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753908

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: Jessica Young, MD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Jessica Young, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01753908     History of Changes
Other Study ID Numbers: I 211911, NCI-2012-01770, P30CA016056, K07CA148888
Study First Received: December 10, 2012
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ductal
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 17, 2014