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Could a walking routine delay resistance to breast cancer therapy?

NCT ID NCT03988595

Disease control Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether a personalized aerobic exercise program, including supervised walking sessions done remotely, can be safely added to the usual first-line hormone therapy for metastatic breast cancer. Researchers want to see if exercise helps delay the development of resistance to hormone therapy and slows tumor growth. The study enrolls postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer who are sedentary and starting endocrine-based treatment. The main goal is to find the maximum feasible dose of exercise that patients can complete without needing to modify or interrupt their sessions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A personalized aerobic exercise program, including supervised walking sessions delivered remotely via tele-exercise, up to 7 times per week for 6 months.
What this could lead to
If exercise proves feasible and beneficial, it could become a standard addition to first-line therapy for metastatic breast cancer, potentially delaying disease progression and improving quality of life.
What could go wrong
This is an early-phase trial focused on feasibility, not effectiveness. The exercise may be hard to sustain, and any benefit on tumor growth or treatment resistance remains unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

54 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hormone receptor positive metastatic breast cancer

Contacts and locations

Locations

  • 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 Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604, United States

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

    The Bronx, New York, 10467, United States

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