NCT03988595

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
3mo left

Started Jun 2019

Longer than P75 for phase_1

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Jun 2019Aug 2026

Study Start

First participant enrolled

June 12, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

7.1 years

First QC Date

June 13, 2019

Last Update Submit

August 26, 2025

Conditions

Hormone Receptor Positive Metastatic Breast Cancer

Keywords

Exercise19-113

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (5)

aerobic training 90 mins/wk

EXPERIMENTAL

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

aerobic training 150 mins/wk

EXPERIMENTAL

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

aerobic training 225 mins/wk

EXPERIMENTAL

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

aerobic training 300 mins/week

EXPERIMENTAL

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

aerobic training 375 mins/week

EXPERIMENTAL

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

Interventions

Exercise TreatmentOTHER

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.

aerobic training 150 mins/wkaerobic training 225 mins/wkaerobic training 300 mins/weekaerobic training 375 mins/weekaerobic training 90 mins/wk

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast Cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Indiana University (Data Collection Only)

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins Hospital (Data Collection Only)

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)

The Bronx, New York, 10467, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jessica Scott, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Exercise therapy will consist of individualized walking delivered 3 to 5 times weekly for 24 weeks. This trial will evaluate four escalated doses of exercise (90 mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/week, or 375 mins/week).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

June 12, 2019

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF

Locations

US(10)