Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01753908
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01753908
Study Brief:
Protocol Section:
NCT01753908