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This study has been withdrawn prior to enrollment.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:
Collaborator:
Information provided by (Responsible Party):
Michael Simon, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01612910
First received: June 4, 2012
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer Female
Drug: oral microencapsulated diindolylmethane
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Estimated using Kaplan-Meier methods with 95% confidence intervals.


Secondary Outcome Measures:
  • Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.


Enrollment: 0
Study Start Date: June 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612910

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Michael Simon, M.D. Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Michael Simon, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01612910     History of Changes
Other Study ID Numbers: 2011-111
Study First Received: June 4, 2012
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Barbara Ann Karmanos Cancer Institute:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014