Breast CancerPhase 2NCT05716893
Study of Aerobic Training for People Receiving Treatment for Breast Cancer
A Phase 2 study testing Adaptive Aerobic Training/AT Dosing and Standard (fixed) Aerobic Training/AT dosing in people with Breast Cancer and Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma
- What is being tested?
- Adaptive Aerobic Training/AT Dosing and Standard (fixed) Aerobic Training/AT dosing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jan 2023to 30 Jan 2028
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Female
- Diagnosed with primary breast cancer as defined by one of the following:
- Histological confirmation
- As per standard of care imaging
- Scheduled to receive neoadjuvant/adjuvant systemic and/or locoregional therapy
Show all 13Show fewer
- Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report
- Willingness to comply with all study-related procedures
- Able to achieve an acceptable peak baseline CPET, 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.
Who cannot join
- Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
- Receiving treatment for any other diagnosis of invasive cancer
- Distant metastatic malignancy of any kind
- Mental impairment leading to inability to cooperate
- Any of the following contraindications to cardiopulmonary exercise testing:
- Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85%
- Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Bergen (Limited protocol activities)
Montvale, New Jersey, 07645
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Jessica Scott, PhD, 646-888-8093
- Recruiting
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, 11553
Jessica Scott, PhD, 646-888-8093
About this study
Official title: Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer
In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.
- Conditions
- Breast Cancer, Breast Carcinoma
- Being tested
- Adaptive Aerobic Training/AT Dosing, Standard (fixed) Aerobic Training/AT dosing
- Keywords
- Breast cancer, Breast carcinoma, Primary breast cancer, Aerobic Training, 22-364, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Aerobic Training/AT DosingBehavioural
- In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week using an adaptive dosing schedule that starts at 90 min/wk and is escalated 30 min/wk every 2 weeks to a maximal dose of 300 mins/wk. In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.
Standard (fixed) Aerobic Training/AT dosingBehavioural
In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week to achieve a cumulative total duration of: 90 min/wk (standard fixed dosing). In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Aerobic Training/AT Dosing | Experimental | Participants with newly diagnosed primary breast cancer initiating chemotherapy. Receives: Behavioral: Adaptive Aerobic Training/AT Dosing |
| Standard (fixed) Aerobic Training/AT dosing | Active comparator | Participants with newly diagnosed primary breast cancer initiating chemotherapy. Receives: Behavioral: Standard (fixed) Aerobic Training/AT dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (CRF) response rate
The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change <3.50 ml O2 .kg-1.min-1 will be considered a non-response.
Measured: 32 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start30 Jan 2023
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Scott, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716893
- Sponsor's protocol ID
- 22-364
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2023
- Last updated
- 27 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 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT05716893
- Acronym / sponsor ID
- 22-364
- Conditions
- Breast Cancer, Breast Carcinoma
- Keywords
- Breast cancer, Breast carcinoma, Primary breast cancer, Aerobic Training, 22-364, Memorial Sloan Kettering Cancer Center
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 8 Feb 2023 (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.
In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Aerobic Training/AT Dosing | Experimental | Behavioral: Adaptive Aerobic Training/AT DosingParticipants with newly diagnosed primary breast cancer initiating chemotherapy. |
| Standard (fixed) Aerobic Training/AT dosing | Active comparator | Behavioral: Standard (fixed) Aerobic Training/AT dosingParticipants with newly diagnosed primary breast cancer initiating chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged ≥18 years
- Female
- Diagnosed with primary breast cancer as defined by one of the following:
- Scheduled to receive neoadjuvant/adjuvant systemic and/or locoregional therapy
- Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report
Key exclusion criteria (7 listed)
- Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes
- Receiving treatment for any other diagnosis of invasive cancer
- Distant metastatic malignancy of any kind
- Mental impairment leading to inability to cooperate
- Any of the following contraindications to cardiopulmonary exercise testing:
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 |
|---|---|---|
| Adaptive Aerobic Training/AT Dosingo In Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week using an adaptive dosing schedule that starts at 90 min/wk and is escalated 30 min/wk every 2 weeks to a maximal dose of 300 mins/wk. In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx. | Behavioural | Adaptive Aerobic Training/AT Dosing |
| Standard (fixed) Aerobic Training/AT dosingIn Phase A (~32 weeks), AT will consist of supervised walking delivered up to 7 days per week to achieve a cumulative total duration of: 90 min/wk (standard fixed dosing). In Phase B (~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ<3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks, or unsupervised AT in patients with a CRF Δ>3.50 ml O2 .kg-1.min-1 from baseline to ~32 weeks. Supervised AT will be monitored using TeleEx. | Behavioural | Standard (fixed) Aerobic Training/AT dosing |
Primary outcome
Cardiorespiratory fitness (CRF) response rate
Time frame: 32 weeks from baseline
The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change <3.50 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 27 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.
Jessica Scott, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptive Aerobic Training/AT Dosing and Standard (fixed) Aerobic Training/AT dosing in people with Breast Cancer and Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 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 13 inclusion and 7 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 27 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 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (646-888-8093, scottj1@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (CRF) response rate (time frame: 32 weeks from baseline). 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 27 Aug 2026.