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

Phase 2

Withdrawn

• Conditions: Breast Cancer Female
• Interventions: Drug: oral microencapsulated diindolylmethane; Other: laboratory biomarker analysis

• Registration Number: NCT01612910
• Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Brief 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-06
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microencapsulated diindolylmethane, lab. biomarker analysis	laboratory biomarker analysis	Patients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity
microencapsulated diindolylmethane, lab. biomarker analysis	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

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS), defined as clear development of new sites of disease, measurable or non-measurable or death	From date of registration to date of first documentation of progression, up to 3 years	Estimated using Kaplan-Meier methods with 95% confidence intervals.

Secondary Outcome Measures

Name	Time	Method
Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression	Up to 3 years	Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.