Trial record 1 of 1 for:    NCT01753908
Previous Study | Return to List | Next Study

Broccoli Sprout Extract in Treating Patients With Estrogen Receptor-Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 28, 2014
Last verified: August 2014

December 10, 2012
August 28, 2014
May 2013
August 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01753908 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Broccoli Sprout Extract in Treating Patients With Estrogen Receptor-Positive Breast Cancer
A Pilot Study of Broccoli Sprout Extract in Patients With Invasive Breast Cancer

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • 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
    Given PO
  • Other: placebo
    Given PO
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I (broccoli sprout extract)
    Patients receive broccoli sprout extract PO QD on days 1-14.
    Interventions:
    • Drug: broccoli sprout extract
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II (placebo)
    Patients receive placebo PO QD on days 1-14.
    Interventions:
    • Other: placebo
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
August 2015   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
United States
 
NCT01753908
I 211911, NCI-2012-01770, P30CA016056, K07CA148888
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Jessica Young, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP