Clinical trial NCT01753908: Broccoli Sprout Extract in Treating Patients With Breast Cancer
Official title: A Pilot Study of Broccoli Sprout Extract in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in apoptosis (cleaved caspase 3)
timeFrame: Baseline to up to 14 days
measure: Changes in cell proliferation (Ki-67)
timeFrame: Baseline to up to 14 days
measure: Changes in estrogen receptor expression (ER alpha and ER beta)
timeFrame: Baseline to up to 14 days
measure: Changes in NQO1 expression
timeFrame: Baseline to up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Jessica Young
role: PRINCIPAL_INVESTIGATOR
References: