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

 -  Participants with a histologically or pathologically confirmed diagnosis of triple
 negative, AR positive invasive breast carcinoma (stage II or III) who have received
 neoadjuvant chemotherapy (anthracycline or taxane or both) who have residual disease
 in their breasts following surgical resection by lumpectomy or mastectomy; androgen
 receptor (AR) testing will be performed on all patients who have residual invasive
 breast cancer after neoadjuvant taxane and/or anthracycline for triple negative breast
 cancer; this will be done under institutional protocol approval; physicians of
 patients who have AR positive tumors will be notified by our research coordinator of
 the potential eligibility for this study

 -  Participants must have undergone definitive surgery with negative margins for breast
 cancer in the past 2 years and must have residual pathologic invasive disease in the
 primary breast or lymph nodes or both; at the time of protocol entry it will be
 determined under good medical practice that there is no evidence for metastatic
 disease; patients should have completed all radiation therapy if indicated at the time
 of study entry

 -  Patients must have a Zubrod performance status of 0-2

 -  Patients must consent to the serum and whole blood specimen submissions

 -  Patients must be able to take oral medications (patients with uncontrolled nausea,
 vomiting, diarrhea at baseline, lack of physical integrity of the upper
 gastrointestinal tract, or malabsorption syndrome, are excluded)

 -  Pregnant or nursing women may not participate in this trial because of the
 increased risk of fetal harm including fetal death from the chemotherapeutic
 agents; women of reproductive potential may not participate unless they have
 agreed to use an effective contraceptive method for the duration of this trial

 -  Patients must be informed of the investigational nature of this study and must
 sign and give written informed consent in accordance with institutional and
 federal guidelines

 -  Granulocyte count > 1,500/mcL

 -  Platelet count > 100,000/mcL

 -  Bilirubin =< 3 x institutional upper limit of normal (IULN)

 -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 5 x IULN

 -  Serum creatinine =< 1.5 x IULN

 Exclusion Criteria:

 -  Patients must not have a current active infection requiring systemic therapy

 -  Patients must not have had a cardiac event within 6 months prior to registration such
 as myocardial infarction (including severe/unstable angina), coronary/peripheral
 artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular
 accident or transient ischemic attack, or pulmonary embolism