Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

March 22, 2024 updated by: Memorial Sloan Kettering Cancer Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

53

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lee Jones, PhD
  • Phone Number: 646-888-8103

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University (Data Collection Only)
        • Contact:
          • Tarah Ballinger, MD
          • Phone Number: 317-944-0920
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital (Data Collection Only)
        • Contact:
          • Jennifer Sheng, MD
          • Phone Number: 410-614-0682
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
    • New York
      • Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Lee Jones, PhD
          • Phone Number: 646-888-8103
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714
        • Principal Investigator:
          • Neil Iyengar, MD
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
        • Contact:
          • Neil Iyengar, MD
          • Phone Number: 646-888-4714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aerobic training 90 mins/wk
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.
Other: Exercise Treatment
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.
Experimental: aerobic training 150 mins/wk
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.
Other: Exercise Treatment
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.
Experimental: aerobic training 225 mins/wk
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.
Other: Exercise Treatment
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.
Experimental: aerobic training 300 mins/week
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.
Other: Exercise Treatment
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.
Experimental: aerobic training 375 mins/week
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.
Other: Exercise Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Neil Iyengar, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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