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


N/A
21 Years
N/A
Open (Enrolling)
Female
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Outcome Measure:

Changes in cell proliferation (Ki-67)

Outcome Description:

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.

Outcome Time Frame:

Baseline to 14 days

Safety Issue:

No

Principal Investigator

Stephen Edge

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

I 211911

NCT ID:

NCT01753908

Start Date:

May 2013

Completion Date:

Related Keywords:

  • 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
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular

Name

Location
Roswell Park Cancer Institute Buffalo, New York  14263