Clinical trial NCT03424915: Exercise, Fitness and Tumor Profiling in Breast Cancer Patients
Official title: Integrative Profiling of Primary Breast Cancer on the Basis of Divergent Exercise Exposure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 42
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSK clinic

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.


Eligibility criteria: 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.

Primary outcomes:
measure: differences in DNA somatic mutational profile
timeFrame: 2 years
measure: differences in RNA sequencing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent and Follow-up)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent and Follow-up)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent and Follow-up)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Consent and Follow-up)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent and Follow-up)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (Consent and Follow-up)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent and Follow-up)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Jones, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: