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Breast Cancer FemalePhase 2NCT01612910

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

A Phase 2 study testing oral microencapsulated diindolylmethane and laboratory biomarker analysis in people with Breast Cancer Female, run by Barbara Ann Karmanos Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
oral microencapsulated diindolylmethane and laboratory biomarker analysis
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2012to Feb 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
oral microencapsulated diindolylmethane, laboratory biomarker analysis
Keywords
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
Medical subject headings
Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oral microencapsulated diindolylmethaneDrug

    Also called BioResponse DIM, BR-DIM

    Patients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01612910
Study groupRoleWhat they receive
microencapsulated diindolylmethane, lab. biomarker analysisExperimentalPatients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity
Receives: Drug: oral microencapsulated diindolylmethane; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

Secondary outcomes (2)

  1. Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression

    Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.

    Measured: Baseline

  2. Association of serum BR-DIM levels and changes in correlative biomarkers with time to progression

    Levels of correlative biomarkers explored using a proportional hazards model, with biomarkers parameterized as time-dependent covariates.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

Why it stopped: Research cancelled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612910
Sponsor's protocol ID
2011-111
Status last verified
Feb 2014
First submitted
4 Jun 2012
Last updated
12 Feb 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing oral microencapsulated diindolylmethane and laboratory biomarker analysis in people with Breast Cancer Female, run by Barbara Ann Karmanos Cancer Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2014.

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