Exercise, Fitness and Tumor Profiling in Breast Cancer Patients

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Breast Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT03424915

18-058

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

42 participants in 2 patient groups

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

Description:

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.

Treatment:

Procedure: Research Tissue sampling

Other: Blood draw

Other: CPET Procedures

Behavioral: Harvard Health Professionals survey

Other: stool sample

Regular exercisers who are at high risk of developing breast cancer

Description:

≥120 minutes of vigorous-intensity aerobic exercise;

Treatment:

Procedure: Research Tissue sampling

Behavioral: Harvard Health Professionals survey