Exercise, Fitness and Tumor Profiling in Breast Cancer Patients



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - 80
Updated:2/23/2019
Start Date:January 31, 2018
End Date:January 2020
Contact:Neil Iyengar, MD
Email:iyengarn@mskcc.org
Phone:646-888-4714

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

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 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.


Inclusion Criteria:

- 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 ≥5mm, 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

Exclusion Criteria:

- 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.
We found this trial at
7
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Rockville Centre, New York 11570
Phone: 646-888-4714
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136 Mountainview Boulevard
Basking Ridge, New Jersey 07920
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Commack, New York 11725
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Harrison, New York
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480 Red Hill Road
Middletown, New Jersey 07748
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225 Summit Avenue
Montvale, New Jersey 07645
Phone: 646-888-4714
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Neil Iyengar, MD
Phone: 646-888-4714
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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