Dose-Response of Aerobic Training in Women at High-Risk for Development of Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- High Risk for Developing Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.
The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women at high-risk of breast cancer as defined by one of the following:
- •Cytologically confirmed atypical hyperplasia
- •Cytologically confirmed LCIS
- •Being a carrier for
- •BRCA1 and/or BRCA2
- •Predicted lifetime risk of breast cancer \>20% based on family history)
- •Predicted 10-year risk of breast cancer of ≥ 2.31%
- •Predicted 5-year risk of breast cancer ≥ 1.67%
- •Aged 21 ≤ 80 years old
- •If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study.
Exclusion Criteria
- •Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of randomization, including, but not limited to: (tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole)
- •Enrollment on an interventional investigational study
- •Bilateral breast implants
- •Any newly identified breast abnormality requiring surgical excision
- •History of any of the following:
- •Invasive cancer diagnosis
- •Any current invasive cancer diagnosis
- •Metastatic malignancy of any kind
- •Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for core biopsy or the trial
- •Mental impairment leading to inability to cooperate.
Outcomes
Primary Outcomes
gene expression patterns of non-neoplastic breast epithelial cells in women at high-risk for development of breast cancer
Time Frame: 2 years
Fresh-frozen tissue sections from normal breast epithelial cell samples before and after aerobic training will be cut and stained using hematoxylin \& eosin, and the morphological features will be reviewed.