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Completed

NCT Number: NCT01753908

Broccoli Sprout Extract in Treating Patients With Breast Cancer

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.

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Key information

Conditions

Ductal Breast Carcinoma Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Ductal Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating Carcinoma, Lobular Ductal Breast Carcinoma In Situ Estrogen Receptor Negative Estrogen Receptor Positive Invasive Breast Carcinoma Lobular Breast Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Postmenopausal Skin Diseases Skin and Connective Tissue Diseases Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broccoli Sprout Extract

Drug

Given PO

laboratory biomarker analysis

Other

Correlative studies

pharmacological study

Other

Urinary ITCs and metabolites measured

Placebo

Other

Given PO

Other names: placebo therapy, PLCB, sham therapy

Primary outcomes

  1. Changes in apoptosis (cleaved caspase 3)

    Time frame: 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.

  2. Changes in cell proliferation (Ki-67)

    Time frame: 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.

  3. Changes in estrogen receptor expression (ER alpha and ER beta)

    Time frame: 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.

  4. Changes in NQO1 expression

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2012
Registry last updated
Oct 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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