Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Regular exercisers and non-exercising groups who have been diagnosed with breast cancer

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.

Harvard Health Professionals survey

Intervention Type BEHAVIORAL

Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.

Blood draw

Intervention Type OTHER

Participant will provide a blood sample

CPET Procedures

Intervention Type OTHER

CPET with 12-lead ECG

stool sample

Intervention Type OTHER

Research stool sample (within ±1 week of surgery), if possible

Research Tissue sampling

Intervention Type PROCEDURE

Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.

Regular exercisers who are at high risk of developing breast cancer

≥120 minutes of vigorous-intensity aerobic exercise;

Harvard Health Professionals survey

Intervention Type BEHAVIORAL

Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.

Research Tissue sampling

Intervention Type PROCEDURE

Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.

Interventions

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Harvard Health Professionals survey

Participants will be asked a series of questions (using a validated questionnaire) to assess self-reported exercise exposure over the past 12 months.

Intervention Type BEHAVIORAL

Blood draw

Participant will provide a blood sample

Intervention Type OTHER

CPET Procedures

CPET with 12-lead ECG

Intervention Type OTHER

stool sample

Research stool sample (within ±1 week of surgery), if possible

Intervention Type OTHER

Research Tissue sampling

Sample of the tumor and normal breast tissue may be taken from the tissue removed during breast cancer surgery if there is enough tissue left over for research testing.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No