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NCT05468034Recruiting

Exercise in Metastatic Breast Cancer: EMBody

Source: ClinicalTrials.gov · Last updated 27 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
12 Jul 2022
Start date
26 Apr 2023
Primary completion date
Dec 2027
Lead sponsor
Indiana University
NCT number
NCT05468034

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 26 Apr 2023 to the primary completion date, Dec 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other

  • Active, untreated brain metastases

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IU Health West
Coordinator of this site? Confirm its status
AvonUnited StatesWithdrawn
Dana-Farber Cancer Institute
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
IU Health Joe and Shelly Schwarz Cancer Center
Coordinator of this site? Confirm its status
CarmelUnited StatesWithdrawn
Sidney and Lois Eskenazi Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesWithdrawn
Indiana University Melvin & Bren Simon Cancer Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Yale Cancer Center
Coordinator of this site? Confirm its status
New HavenUnited StatesCompleted

This page is information, not medical advice. Discuss any trial with your doctor.