Recruiting
Phase 2

Standard AT vs. Adaptive AT

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05716893

Conditions

Breast Cancer

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adaptive Aerobic Training/AT Dosing

Standard (fixed) Aerobic Training/AT dosing

Study Details

Brief 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. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.

Conditions

Breast Cancer

Breast Carcinoma

Study ID

NCT05716893

Start date

Jan 30, 2023

Status verified date

Aug, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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:

1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
2. A respiratory exchange ratio ≥ 1.10;
3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.

Exclusion Criteria:

  • 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:

i. 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

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Adaptive Aerobic Training/AT Dosing

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

active comparator: Standard (fixed) Aerobic Training/AT dosing

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Interventions

Adaptive Aerobic Training/AT Dosing

o 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 dosing

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.

Primary outcome measure

  • Cardiorespiratory fitness (CRF) response rate [ Time Frame: 32 weeks from baseline ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Bergen (Limited protocol activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jessica Scott, PhD

646-888-8093

Memorial Sloan Kettering Nassau (Limited protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Jessica Scott, PhD

646-888-8093

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Breast cancer
  • Breast carcinoma
  • Primary breast cancer
  • Aerobic Training
  • 22-364
  • Memorial Sloan Kettering Cancer Center

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 2026-08-27.