Breast Cancer Female Clinical Trial
Official title:
A Pilot Study of BR-DIM in Women With Stage II-III, Triple Negative, and Androgen Receptor Positive, Invasive Breast Cancer, Who Have Residual Disease Following Surgical Resection After Neoadjuvant Chemotherapy
This study is being done to find out whether a nutritional supplement, called BioResponse-DIM (BR-DIM [oral microencapsulated diindolylmethane]), improves the survival for women who have residual cancer cells following surgery after chemotherapy for breast cancer. BR-DIM is an active ingredient in cruciferous vegetables (broccoli, brussels sprouts and cauliflower). Consumption of these vegetables has been associated with a decreased risk in several cancers. Researchers also hope to find out whether different biomarkers (also called "markers") in the blood predict the chance of breast cancer returning. BR-DIM is thought to be effective in treating stage II-III breast cancer that is triple negative, AR positive (+), and where there is residual cancer cells in the breast after chemotherapy.
Patients receive oral microencapsulated diindolylmethane orally (PO) twice daily (BID) for 1
year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 3 years.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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