Status:
ACTIVE_NOT_RECRUITING
Exercise, Fitness and Tumor Profiling in Breast Cancer Patients
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-80 years
Brief 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 ho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Cohort 1:
- Received any form of neoadjuvant treatment
- Presence of any other concurrent, actively treated malignancy
- Presence of metastatic disease
- If performing a CPET, any of the following contraindications:
- Acute myocardial infarction within 3-5 days of any planned study procedures;
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis).
- Mental impairment leading to inability to cooperate
- If performing a CPET, room air desaturation at rest ≤ 85%
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the study.
- Cohort 2:
- Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of consent, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole.
- Enrollment on an interventional investigational study
- Bilateral breast implants
- History of any of the following:
- Invasive breast cancer
- DCIS
- Any current invasive cancer diagnosis
- Metastatic malignancy of any kind
- If performing a CPET, any of the following contraindications:
- Acute myocardial infarction within 3-5 days of any planned study procedures;
- Unstable angina
- Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
- Recurrent syncope
- Active endocarditis
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
- Thrombosis of lower extremities
- Suspected dissecting aneurysm
- Uncontrolled asthma
- Pulmonary edema
- Respiratory failure
- Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis).
- Mental impairment leading to inability to cooperate
- If performing a CPET, room air desaturation at rest ≤ 85%
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the core biopsy or the study.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03424915
Start Date
January 31 2018
End Date
January 1 2026
Last Update
July 4 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent and Follow-up)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent and Follow-up)
Commack, New York, United States, 11725