Early Stage Breast CancerNCT04458532
Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer
A study testing Aerobic Training in people with Early Stage Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Aerobic Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2020to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lee Jones, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut, 06102
Andrew Salner, MD, 860-972-2803
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Jessica Scott, PhD, 646-888-8103
Lee Jones, PhD, 646-888-8103
About this study
Official title: A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer
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.
Read the detailed description
Prior to the initiation of every supervised aerobic training session, patient resting vital signs will be assessed to ensure the patient can safely proceed with the session. Vital signs, including resting heart rate and blood pressure, will be collected and monitored per ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc staff member observes any concerns that may compromise participant safety and/or the integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Aerobic Training
- Keywords
- Exercise Therapy, Aerobic Training, Post-Menopausal Women, 20-130
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic TrainingOther
300 min/wk for 16 weeks
Aerobic TrainingOther
150 min/wk for 32 weeks
Aerobic TrainingOther
300 min/wk for 32 weeks
Aerobic TrainingOther
150 min/wk for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| (A) breast cancer after completion of chemo | Experimental | 300 min/wk for 16 weeks, followed by 16 weeks of usual care. Receives: Other: Aerobic Training |
| (B) breast cancer after completion of chemo | Experimental | 150 min/wk for 32 weeks. Receives: Other: Aerobic Training |
| (C) breast cancer after completion of chemo | Experimental | 300 min/wk for 32 weeks. Receives: Other: Aerobic Training |
| (D) breast cancer after completion of chemo | Active comparator | 150 min/wk for 16 weeks, followed by 16 weeks of usual care. Receives: Other: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate
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.
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start8 Oct 2020
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center randomized controlled trial (RCT) study designed to evaluate the cardiorespiratory fitness (CRF) response rate to different aerobic therapy (AT) doses in patients with post-treatment primary breast cancer.
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04458532
- Sponsor's protocol ID
- 20-130
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2020
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT04458532
- Acronym / sponsor ID
- 20-130
- Conditions
- Early Stage Breast Cancer
- Keywords
- Exercise Therapy, Aerobic Training, Post-Menopausal Women, 20-130
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prior to the initiation of every supervised aerobic training session, patient resting vital signs will be assessed to ensure the patient can safely proceed with the session. Vital signs, including resting heart rate and blood pressure, will be collected and monitored per ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc staff member observes any concerns that may compromise participant safety and/or the integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a single-center randomized controlled trial (RCT) study designed to evaluate the cardiorespiratory fitness (CRF) response rate to different aerobic therapy (AT) doses in patients with post-treatment primary breast cancer.
| Arm | Type | Receives |
|---|---|---|
| (A) breast cancer after completion of chemo | Experimental | Other: Aerobic Training300 min/wk for 16 weeks, followed by 16 weeks of usual care. |
| (B) breast cancer after completion of chemo | Experimental | Other: Aerobic Training150 min/wk for 32 weeks. |
| (C) breast cancer after completion of chemo | Experimental | Other: Aerobic Training300 min/wk for 32 weeks. |
| (D) breast cancer after completion of chemo | Active comparator | Other: Aerobic Training150 min/wk for 16 weeks, followed by 16 weeks of usual care. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Aged 21-80 years
- Female
- Surgically resected early stage (I-III) primary breast cancer
- Post-menopausal, defined as one of the following:
- 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:
Key exclusion criteria (22 listed)
- Any of the following absolute contraindications to cardiopulmonary exercise testing:
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Training300 min/wk for 16 weeks | Other | (A) breast cancer after completion of chemo |
| Aerobic Training150 min/wk for 32 weeks | Other | (B) breast cancer after completion of chemo |
| Aerobic Training300 min/wk for 32 weeks | Other | (C) breast cancer after completion of chemo |
| Aerobic Training150 min/wk for 16 weeks | Other | (D) breast cancer after completion of chemo |
Primary outcome
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lee Jones, PhD contact
Jessica Scott, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training in people with Early Stage Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Scott, PhD (646-888-8103, scottj1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.