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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This study has been withdrawn prior to enrollment.
(Research cancelled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01612910
First Posted: June 6, 2012
Last Update Posted: February 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Michael Simon, Barbara Ann Karmanos Cancer Institute
June 4, 2012
June 6, 2012
February 12, 2014
June 2012
February 2014   (Final data collection date for primary outcome measure)
Progression Free Survival (PFS), defined as clear development of new sites of disease, measurable or non-measurable or death [ Time Frame: From date of registration to date of first documentation of progression, up to 3 years ]
Estimated using Kaplan-Meier methods with 95% confidence intervals.
Same as current
Complete list of historical versions of study NCT01612910 on ClinicalTrials.gov Archive Site
  • Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression [ Time Frame: Baseline ]
    Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.
  • Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression [ Time Frame: Up to 3 years ]
    Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer Female
  • 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 Name: BioResponse DIM, BR-DIM
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: microencapsulated diindolylmethane, lab. 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
Interventions:
  • Drug: oral microencapsulated diindolylmethane
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01612910
2011-111
Yes
Not Provided
Not Provided
Michael Simon, Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Michael Simon, M.D. Barbara Ann Karmanos Cancer Institute
Barbara Ann Karmanos Cancer Institute
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP