Exercise in Metastatic Breast Cancer: EMBody

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Indolent Metastatic Breast Cancer

In brief

The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.

Key facts

Study ID

NCT05468034

Run by

Indiana University

People needed

100

Starts

2023-04-26

Expected to finish

2027-12-01

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Diagnosis of metastatic breast cancer
• No progression of disease in the 12 months prior to screening per the treating investigator
• If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
• Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
• ECOG performance status of 0-2
• Ability to walk on a treadmill without assistive device.
• Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
• Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the IPAQ questionnaire administered during screening)
• Participants should have a cellular device compatible with iOS 15 or Android operating system 7.

You may not qualify if…

• Receiving cytotoxic chemotherapy at any point in the prior 12 months.
• Participants receiving endocrine therapy are eligible.
• Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
• Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supersede this eligibility criteria.
• NYHA class III or IV congestive heart failure
• Uncontrolled angina
• Myocardial infarction in the prior 12 months
• Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
• Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
• Symptomatic peripheral vascular disease
• Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness
• History of fragility fracture
• Active, untreated brain metastases

Where it is running

• Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States
• IU Health West — Avon, Indiana, United States
• IU Health Joe and Shelly Schwarz Cancer Center — Carmel, Indiana, United States
• Sidney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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