Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03424915
• Other study ID #: 18-058
• Status: Active, not recruiting
• Start date: January 31, 2018
• Est. completion date: January 2026

Study information

• Verified date: August 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• 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.

Other:
• Blood draw
Participant will provide a blood sample
• CPET Procedures
CPET with 12-lead ECG
• stool sample
Research stool sample (within ±1 week of surgery), if possible

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Consent and Follow-up)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent and Follow-up)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent and Follow-up)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent and Follow-up)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (Consent and Follow-up)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent and Follow-up)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in DNA somatic mutational profile	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.	2 years
Primary	differences in RNA sequencing	The initial analysis will focus on immune signatures (i.e., immune activation, as well as preexisting immune and related signatures) characterization using RNA-seq	2 years

External Links

•   Memorial Sloan Kettering Cancer Center