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

Memorial Sloan Kettering Cancer Center10 sites in 1 country54 target enrollmentJune 12, 2019

ConditionsHormone Receptor Positive Metastatic Breast Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hormone Receptor Positive Metastatic Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 54
Locations: 10
Primary Endpoint: maximum feasible dose (MFD)
Status: Active, not recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 12, 2019

End Date

August 1, 2026

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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%.