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Breast NeoplasmsNCT02681120

Pilot Study of the Effect of Weight Loss on Breast Tissue and Blood Biomarkers in Women at Increased Risk for Breast Cancer

An observational study of Breast Neoplasms and Obesity, run by Tarah J Ballinger, MD at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Neoplasms, Obesity
What is being tested?
Biopsy, Blood draw and Mammogram
Type of treatment
Surgery or procedure
How many people
3 participants
Where
3 sitesUnited States
Study dates
7 Oct 2016to 30 Jan 2020
Phase
Observational
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 20 total patients will be enrolled to the high risk/BMI > 30 cohort. Post-menopausal women are defined as: (1) those ≥ 50 years of age who had not menstruated during the preceding 12 months or who had castrate follicle-stimulating hormone levels (>40IU/L), (2) those who had undergone a bilateral oophorectomy.

Who may be able to join

  • Patients must be post-menopausal, defined as one of the following:
  • Age over 60
  • Prior oophorectomy
  • No menstrual periods in the past 12 months without a medical procedure such as hysterectomy or uterine ablation
  • FSH at castrate levels (> 40IU/L). Patients who do not meet criteria a-c (such as those under age 60 with prior hysterectomy but ovaries remain in place) will need to have an FSH level to confirm menopausal status prior to enrollment.
  • Patients must have a BMI ≥ 30 as calculated by the formula:
Show all 16Show fewer
  • Weight in pounds / height squared x 703 = BMI
  • A BMI of:
  • 18.5-24.9 is considered normal;
  • 25.0-29.9 is considered overweight;
  • 30.0+ is regarded as obese.
  • Patients must be planning to undergo primary bariatric surgery (no revisions).
  • Patients must be willing to provide a core tissue biopsy at baseline and with repeat tissue collection after 2 weeks and 12 months post-bariatric surgery.
  • Patients must be aged 18-75 years at the time of informed consent.
  • Patients must be accessible for treatment, adverse event tracking and follow-up as determined by the treating physician.
  • Patient consent and authorization for the release of health information must be obtained according to local institutional guidelines.

Who cannot join

  • History of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years. History of breast cancer is not allowed.
  • Concurrent or planned participation in randomized trials of weight loss or exercise interventions or trials targeting insulin, IGF-1 or their receptors. These interventions would interfere with the endpoints.
  • Weight greater than 500 lbs at the time of imaging.
  • Known allergy to gadolinium which is used for MRI contrast.
  • History of life threatening allergic reaction to local anesthesia (lidocaine, xylocaine).
  • For the purposes of invasive breast biopsies, women must not have received therapeutic anticoagulation in the 1 month prior to enrollment, and must have no medical reason why post-operative prophylactic anticoagulation could be held for 12 hours (i.e. atrial fibrillation, history of deep venous thrombosis).
  • Prior history of breast irradiation.
  • Use of chemopreventatives such as tamoxifen or raloxifene at any time prior to enrollment.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

This is a pilot, non-randomized, single institution, observational study investigating the effect of dramatic weight loss secondary to bariatric surgery on biomarkers of breast cancer in tissue and blood as well as on imaging in women at elevated risk for breast cancer. Twelve months after bariatric surgery, 50% of excess weight is generally expected. Eligible women at elevated risk for breast cancer who are already planning to undergo bariatric surgery will be consented to undergo imaging (MRI and mammogram), breast tissue biopsy, and fasting blood draw prior to bariatric surgery, approximately 14 days after bariatric surgery, and approximately 1 year after bariatric surgery.

In parallel we will also be assessing 40 normal breast tissue specimens as well as blood samples from the Komen Tissue Bank (elevated risk but normal BMI) to establish a normal BMI, elevated risk control group for our study. The KTB samples will be matched for general risk of breast cancer (>20%), age, race and menopausal status.

Read the detailed description

Primary Objectives

  1. The effect of bariatric surgery on Background Parenchymal Enhancement (BPE) on breast MRI through comparative analysis of images of women pre- and 1 year post-bariatric surgery.
  2. The effect of bariatric surgery on breast density as seen on standard four view mammograms by qualitative BIRADS category through comparative analysis of images of women pre- and 1 year post-bariatric surgery. Secondary Objectives
  3. The impact of bariatric surgery on obesity associated immune markers in breast tissue by:
  • Comparing cellular immune infiltrate components [B cells (CD 20), cytotoxic T cells (CD8), helper T cells (CD4), dendritic cells (CD11c), leukocytes (CD45), and monocytes/macrophages (CD68)] in breast tissue lobules of obese women pre-, 14 days post, and 1 year post bariatric surgery, and comparing these to normal breast tissue of lean women from the KTB
  • Comparing the presence of crown like structures (CLS) in breast tissue of obese women at pre-, 14 day post-, and 1 year post - bariatric surgery, and comparing these also to normal breast tissue of lean women from the KTB.
  1. The effect of bariatric surgery on aromatase expression in breast tissue of obese women pre-, 14 day post-, and 1 year post-bariatric surgery, as compared to levels in breast tissue of lean women from KTB.
  2. The effects of bariatric surgery on other blood correlatives pre- and 14 day and 1 year post-bariatric surgery including: 1) PGE2, TNF alpha, IL1 beta, IL-8 and IL-10 in the inflammatory pathway; 2) adiponectin, leptin, insulin, IGF1, and IGFBP3 in the insulin pathway; and 3) estradiol, SHBG, E2, T and DHEAS in the hormonal pathway. These will also be compared to blood samples from lean women in the KTB.
Being tested
Biopsy, Blood draw, Mammogram, MRI
Keywords
Biomarkers, Breast imaging
Medical subject headings
Breast Neoplasms, Obesity

What participants receive

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

  • BiopsyProcedure or surgery

  • Blood drawProcedure or surgery

  • MammogramProcedure or surgery

  • MRIProcedure or surgery

Study groups in NCT02681120
Study groupRoleWhat they receive
High risk/BMI > 30Women at elevated risk for breast cancer will have imaging (MRI and mammogram) pre-bariatric surgery and 1 year post-bariatric surgery, and blood and tissue collection (blood draw and biopsy) pre-bariatric surgery, 2 weeks post-bariatric surgery, and 1 year post-bariatric surgery.
Receives: Procedure: Biopsy; Procedure: Blood draw; Procedure: Mammogram; Procedure: MRI
Women with normal BMIDeidentified samples that were donated to the IU Komen Tissue Bank will be used for comparison to the high risk/BMI > 30 cohort.

What is being measured

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

  1. Change in breast density via MRI from baseline

    Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change

    Measured: 1 year post-bariatric surgery

  2. Change in breast density via mammography from baseline

    Categorical measures will be reported numerically: 1-increased, 2-decreased, 3-no change

    Measured: 1 year post-bariatric surgery

Secondary outcomes (8)

  1. Comparison of number of crown-like structures in obese breast tissue and normal breast tissue

    Numerical measures

    Measured: 14 days post-bariatric surgery

  2. Comparison of number of crown-like structures in obese breast tissue and normal breast tissue

    Numerical measures

    Measured: 1 year post-bariatric surgery

  3. Change in aromatase expression markers in obese tissue from baseline

    Numerical measures

    Measured: 14 days post-bariatric surgery

  4. Comparison of aromatase expression markers in normal weight breast tissue with obese breast tissue

    Numerical measures

    Measured: 14 days post-bariatric surgery

  5. Change in aromatase expression markers in obese tissue from baseline

    Numerical measures

    Measured: 1 year post-bariatric surgery

  6. Comparison of aromatase expression markers in normal weight breast tissue with obese breast tissue

    Numerical measures

    Measured: 1 year post-bariatric surgery

  7. Change in other correlative blood markers (inflammatory, insulin, hormonal) from baseline

    Numerical measures

    Measured: 14 days post-bariatric surgery

  8. Change in other correlative blood markers (inflammatory, insulin, hormonal) from baseline

    Numerical measures

    Measured: 1 year post-bariatric surgery

Timeline

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

  1. First posted12 Feb 2016 (estimated)
  2. Study start7 Oct 2016
  3. Primary completion30 Jan 2020
  4. Study completion30 Jan 2020

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02681120
Sponsor's protocol ID
IUSCC-0556
Other IDs
1511957605
Status last verified
Oct 2021
First submitted
9 Feb 2016
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms and Obesity, run by Tarah J Ballinger, MD at 3 sites in United States.

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 16 inclusion and 8 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in breast density via MRI from baseline (time frame: 1 year post-bariatric surgery). The study lists 2 primary outcomes in all. 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 NCT02681120.

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 14 Oct 2021.

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