NCT01612910

Oral Microencapsulated Diindolylmethane in Treating Patients With Stage II-III Triple Negative, Androgen Receptor Positive Breast Cancer Who Have Undergone Chemotherapy and Surgery

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
DRUG	oral microencapsulated diindolylmethane	Patients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-06-06
• Last updated: 2014-02-12