Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

This study will test any good and bad effects of aerobic exercise performed while you are receiving the usual first-line treatment for metastatic breast cancer. The researchers think that exercise helps delay the development of resistance to hormone therapy while slowing the growth of tumors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hormone Receptor Positive Metastatic Breast Cancer Behavior Motor Activity

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University (Data Collection Only), Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)
Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
Receiving first line endocrine-based therapy (tamoxifen, aromatase inhibitor, or fulvestrant; concurrent molecular therapy also allowed)
Sedentary (i.e., <60 minutes / week of exercise)
Age >18 years
BMI ≥ 18.5
Cleared for exercise participation as per screening clearance via PAR-Q+
Cleared for study participation as per screening consultation with an MSK Exercise Physiologist
Willingness to comply with all study-related procedures
Patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled

Exclusion criteria

Life expectancy <6 months
Enrollment onto any other therapeutic investigational study
Mental impairment leading to inability to cooperate
Concurrent participation in weight loss or other exercise programs

Treatment and study plan

Exercise treatment

Other

Exercise sessions will consist of individualized, walking delivered following a non-linear (i.e.,exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule up to 7 individual treatment sessions/wk for 6 months. Remote supervised exercise sessions will be implemented and monitored using TeleEx. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.

Primary outcomes

maximum feasible dose (MFD)

Time frame: 24 weeks

Feasibility is defined in terms of the relative dose intensive (RDI), the proportion of the planned exercise prescription that was completed without requiring a dose modification or interruption. The MFD is defined as the dose estimated to result in approximately 70% of patients achieving an RDI ≥ 75%.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer

Important dates

Study start: 2019
Primary completion: 2026
Study completion: 2026
First posted: Jun 17, 2019
Registry last updated: Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting