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Exercise Treatment for Breast Cancer

Phase 1

Waitlist Available

Led By Neil Iyengar, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically-confirmed, HR-positive (ER and/or PR), HER2-negative metastatic breast cancer (MBC)

Age >18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the benefits and risks of aerobic exercise for patients with metastatic breast cancer who are receiving hormone therapy. Researchers think that exercise may help delay the development of resistance to hormone therapy and slow the growth of tumors.

Who is the study for?

This trial is for postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer who are sedentary and starting first-line endocrine therapy. They must be cleared for exercise, willing to follow study procedures, have a BMI of at least 18.5, and can't be in other exercise or weight loss programs or have a life expectancy under six months.

What is being tested?

The study is examining the effects of aerobic exercise alongside standard first-line treatment for metastatic breast cancer. The goal is to see if exercise can help delay resistance to hormone therapy and slow tumor growth.

What are the potential side effects?

While specific side effects aren't listed for the exercise intervention, typical risks might include muscle soreness, fatigue, joint pain or injury from physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is HR-positive and HER2-negative.

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I am older than 18 years.

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I am postmenopausal due to no periods for 2 years, surgery, or treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

maximum feasible dose (MFD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: aerobic training 90 mins/wkExperimental Treatment1 Intervention

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.

Group II: aerobic training 375 mins/weekExperimental Treatment1 Intervention

Group III: aerobic training 300 mins/weekExperimental Treatment1 Intervention

Group IV: aerobic training 225 mins/wkExperimental Treatment1 Intervention

Group V: aerobic training 150 mins/wkExperimental Treatment1 Intervention

0 / 3Eligibility criteria met