Broccoli Sprout Extract in Treating Patients With Breast Cancer

Completed · Early Phase 1 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01753908

Run by

Roswell Park Cancer Institute

People needed

30

Starts

2013-05-21

Expected to finish

2018-08-23

Last updated by the study team

2019-10-31

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Roswell Park Cancer Institute — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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