Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
Sponsor study identifier
interventional
54
1 country
10
Study Start
June 12, 2019
Actual (reported)Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2019
Actual (reported)June 13, 2019
Actual (reported)June 17, 2019
Actual (reported)August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
maximum feasible dose (MFD)
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%.
24 weeks
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Indiana University (Data Collection Only)
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hospital (Data Collection Only)
Baltimore, Maryland, 21287, United States
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)
Commack, New York, 11725, United States
Jessica Scott, PhD
Memorial Sloan Kettering Cancer Center
54 participants (actual enrollment reported by the registry).
First Submitted
June 13, 2019
First Posted
June 17, 2019
Study Start
June 12, 2019
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.
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.
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.
Contact the study team to confirm eligibility.
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)
The Bronx, New York, 10467, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Primary Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 31, 2026
Record last verified: 2026-08
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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Source: ClinicalTrials.gov.
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