Exercise, Fitness and Tumor Profiling in Breast Cancer Patients (NCT03424915) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Exercise, Fitness and Tumor Profiling in Breast Cancer Patients
United States42 participantsStarted 2018-01-31
Plain-language summary
This study is designed to find out how engaging in regular exercise (or not) alters the biology of breast tumors as well as the normal tissue (if available) surrounding the tumor. The investigators hope that findings from this initial study will guide the design of future studies to examine how changes in exercise alter breast tumor biology.
Who can participate
Age range21 Years – 80 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cohort 1: Breast Cancer Patients
* Ages 21-80 years
* Female
* Histologically confirmed ER receptor positive (\>1% staining), HER2 negative (FISH ratio \<1.8), untreated operable breast cancer
* Stage I to II disease
* Scheduled for surgical resection by any type of mastectomy or lumpectomy at MSK
* Tumor size ≥1cm by preoperative imaging or physical examination
* Categorization into self-reported exercise history exposure classifications as follows: (1) exercising: ≥120 minutes of vigorous-intensity exercise/wk for the past 12 months, and (2) sedentary (non-exercising): ≤ 30 minutes of moderate-intensity exercise/week for the past months using the Harvard Health Professionals survey.(34)
* Ability to read and understand English
* Willing and able to comply with requirements of the protocol
Cohort 2: High-Risk Patients
* Women at high-risk of breast cancer, as defined by one of the following:
* Cytologically confirmed atypical hyperplasia
* 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.
* Women \<50 years old of child-bearing potential must have a negative pregnancy test (urine HCG or serum) within 14 days of enrollment.
Exc…