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

NCT02681120 | Completed DMC

• 2 other identifiers: IUSCC-05561511957605
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Breast Neoplasms; Obesity

Keywords

Biomarkers; Breast imaging

Outcome Measures

Primary Outcomes (2)

• Change in breast density via MRI from baseline

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

  1 year post-bariatric surgery

• Change in breast density via mammography from baseline

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

  1 year post-bariatric surgery

Secondary Outcomes (8)

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

  14 days post-bariatric surgery

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

  1 year post-bariatric surgery

• Change in aromatase expression markers in obese tissue from baseline

  14 days post-bariatric surgery

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

  14 days post-bariatric surgery

• Change in aromatase expression markers in obese tissue from baseline

  1 year post-bariatric surgery

Study Arms (2)

High risk/BMI > 30

Women 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.

Procedure: Biopsy; Procedure: Blood draw; Procedure: Mammogram; Procedure: MRI

Women with normal BMI

Deidentified samples that were donated to the IU Komen Tissue Bank will be used for comparison to the high risk/BMI \> 30 cohort.

Interventions

Biopsy PROCEDURE

High risk/BMI > 30

Blood draw PROCEDURE

High risk/BMI > 30

Mammogram PROCEDURE

High risk/BMI > 30

MRI PROCEDURE

High risk/BMI > 30

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Study examining changes in female breast tissue pre and post-bariatric surgery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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:
• Weight in pounds / height squared x 703 = BMI
• A BMI of:
• is considered normal;
• is considered overweight;
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarah J Ballinger, MD: lead

Study Sites (3)

Indiana University Health North Hospital

Carmel, Indiana, 46032, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Obesity

Interventions

Biopsy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Punctures

Study Officials

• Tarah Ballinger, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: October 7, 2016
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (3)