Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Active, not recruiting

Conditions: Breast Cancer

Interventions: Behavioral: Harvard Health Professionals survey
Procedure: Research Tissue sampling
Other: Blood draw
Other: CPET Procedures
Other: stool sample

Registration Number: NCT03424915

Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 hope that findings from this initial study will guide the design of future studies to examine how changes in exercise alter breast tumor biology.

Detailed Description: Not available

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: Female

Target Recruitment: 42

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.

Exclusion Criteria

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.

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer	CPET Procedures	There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
Regular exercisers who are at high risk of developing breast cancer	Research Tissue sampling	≥120 minutes of vigorous-intensity aerobic exercise;
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer	Blood draw	There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
Regular exercisers who are at high risk of developing breast cancer	Harvard Health Professionals survey	≥120 minutes of vigorous-intensity aerobic exercise;
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer	Research Tissue sampling	There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer	Harvard Health Professionals survey	There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.
Regular exercisers and non-exercising groups who have been diagnosed with breast cancer	stool sample	There is no treatment on this study, it is a onetime assessment. exercisers: ≥120 minutes of vigorous-intensity aerobic exercise;There is no treatment on this study, it is a onetime assessment. non-exercisers: ≤ 30 minutes of moderate-intensity exercise per week.

Primary Outcome Measures

Name	Time	Method
differences in DNA somatic mutational profile	2 years	Eight-μm-thick representative sections of the fresh-frozen sample will be microdissected with a needle under a stereomicroscope (Olympus SZ61), to ensure \>70% of tumor cell content as previously described.(36) Matched germline DNA will be microdissected from adjacent normal breast tissue (if available) for each case; to avoid the possibility of morphologically appearing non-neoplastic cells harboring somatic mutations; we will prioritize the microdissection of stromal cells and avoid normal breast ducts and lobules.
differences in RNA sequencing	2 years	The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (7): Memorial Sloan Kettering Commack (Consent and Follow-up)
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Monmouth (Consent and Follow-up)
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Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center (Consent and Follow-up)
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New York, New York, United States
Memorial Sloan Kettering Bergen (Consent and Follow-up)
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Montvale, New Jersey, United States
Memorial Sloan Kettering Nassau (Consent and Follow-up)
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Uniondale, New York, United States
Memorial Sloan Kettering Westchester (Consent and Follow-up)
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Harrison, New York, United States
Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
🇺🇸
Basking Ridge, New Jersey, United States

Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Recruitment & Eligibility

Study & Design

Trial Locations

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