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

What this trial studies

This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.

Conditions in scope

• Early Stage Breast Cancer

Interventions

• Aerobic Training (Other) — 300 min/wk for 16 weeks
• Aerobic Training (Other) — 150 min/wk for 32 weeks
• Aerobic Training (Other) — 300 min/wk for 32 weeks
• Aerobic Training (Other) — 150 min/wk for 16 weeks

Who can join

Women only · Ages 21 Years to 80 Years

Inclusion criteria

• 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:

Exclusion criteria

• 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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2020-10-08
• Primary completion: 2027-03-31
• Last update posted: 2026-03-25
• First posted: 2020-07-07

Sponsor & contact

Lead sponsor: Memorial Sloan Kettering Cancer Center (Other)

Collaborators: National Cancer Institute (NCI)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate (32 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.