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Exercise Therapy for Cardiovascular Health in Post-Menopausal Women After Early Stage Breast Cancer

This study is looking at how different amounts of aerobic exercise can improve heart and lung health in post-menopausal women who have been treated for early-stage breast cancer. Researchers will compare exercise programs that involve 150 or 300 minutes of aerobic training per week, lasting for either 16 or 32 weeks. Aerobic exercise is light-to-moderate physical activity that uses large muscle groups, like walking or cycling. The main goal is to see how well your body uses oxygen (VO2peak) after 32 weeks. You may be able to join if you are a woman between 21 and 80 years old, have had early-stage breast cancer removed by surgery, and are post-menopausal.

Study design
This interventional study plans to enroll 152 participants to compare different aerobic exercise programs.
What's involved
You would participate in supervised and unsupervised aerobic training sessions, with vital signs (heart rate and blood pressure) monitored before supervised sessions.
Compensation
Not stated in the trial record.
Follow-up
Your peak oxygen consumption will be measured at 32 weeks.

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NCT04458532

Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer

Recruiting
NAAges 21–80InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~152 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Aerobic Training

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate
Measured over 32 weeks

Conditions

Early Stage Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
Connecticut1
New York1

Study leadership

  • Jessica Scott, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Jessica Scott, PhD
[email protected]
646-888-8103
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 21-80 years
Female
Surgically resected early stage (I-III) primary breast cancer
Post-menopausal, defined as one of the following:
Age ≥ 45 with no menses for at least 2 years
Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist
Estradiol level of ≤30 pg/mL
An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as:
Surgery plus radiation
Surgery plus chemotherapy
Surgery plus trastuzumab
Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)\].
Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
A respiratory exchange ratio ≥ 1.10;
Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
Willingness to comply with all study-related procedures.

Exclusion

Any of the following absolute contraindications to cardiopulmonary exercise testing:
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 (e.g., infection, renal failure, thyrotoxicosis)
Presence of any other concurrent, actively treated malignancy
History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
Presence of distant metastatic disease (i.e., stage IV)
Room air desaturation at rest ≤ 85%
Mental impairment leading to inability to cooperate.
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.

What this trial measures

  • peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate32 weeks

    A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change \<1.32 ml O2.kg-1.min-1 will be considered a non-response.