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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

Phase 2
18 Years
Not Enrolling
Breast Cancer Female

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS), defined as clear development of new sites of disease, measurable or non-measurable or death

Outcome Description:

Estimated using Kaplan-Meier methods with 95% confidence intervals.

Outcome Time Frame:

From date of registration to date of first documentation of progression, up to 3 years

Safety Issue:


Principal Investigator

Michael Simon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Barbara Ann Karmanos Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 2012

Completion Date:

September 2016

Related Keywords:

  • Breast Cancer Female
  • estrogen receptor-negative breast cancer
  • HER2-negative breast cancer
  • progesterone receptor-negative breast cancer
  • recurrent breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • triple-negative breast cancer
  • Breast Neoplasms



Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201