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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Patients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity
Correlative studies
Progression Free Survival (PFS), defined as clear development of new sites of disease, measurable or non-measurable or death
Estimated using Kaplan-Meier methods with 95% confidence intervals.
Time frame: From date of registration to date of first documentation of progression, up to 3 years
Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression
Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.
Time frame: Baseline
Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression
Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.
Time frame: Up to 3 years
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