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 range
21 Years – 80 Years
Sex
FEMALE
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.