Recruiting

Exercise Therapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04458532

Conditions

Early Stage Breast Cancer

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Aerobic Training

Aerobic Training

Aerobic Training

Aerobic Training

Study Details

Brief summary:

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

Early Stage Breast Cancer

Study ID

NCT04458532

Start date

Oct 8, 2020

Status verified date

Aug, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 70+

Healthy Volunteers: Not accepted

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:

  • 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)\].

Note: Normative values are available up to 80 years of age)

  • 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 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
  • 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.

Study Design

Enrollment

152 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: (A) breast cancer after completion of chemo

300 min/wk for 16 weeks, followed by 16 weeks of usual care.

experimental: (B) breast cancer after completion of chemo

150 min/wk for 32 weeks.

experimental: (C) breast cancer after completion of chemo

300 min/wk for 32 weeks.

active comparator: (D) breast cancer after completion of chemo

150 min/wk for 16 weeks, followed by 16 weeks of usual care.

Interventions

Aerobic Training

300 min/wk for 16 weeks

Aerobic Training

150 min/wk for 32 weeks

Aerobic Training

300 min/wk for 32 weeks

Aerobic Training

150 min/wk for 16 weeks

Primary outcome measure

  • peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate [ Time Frame: 32 weeks ]

Central Contacts and Locations

Central contacts

Jessica Scott, PhD

646-888-8103scottj1@mskcc.org

Lee Jones, PhD

646-888-8103

Locations

Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Andrew Salner, MD

860-972-2803

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Jessica Scott, PhD

646-888-8103

Lee Jones, PhD

646-888-8103

Principal Investigator:

Jessica Scott, PhD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Exercise Therapy
  • Aerobic Training
  • Post-Menopausal Women
  • 20-130

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-26.