Exercise Treatment With Standard Therapy for Metastatic Breast Cancer

Phase 1Active Not RecruitingNCT03988595

Memorial Sloan Kettering Cancer Center54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hormone Receptor Positive Metastatic Breast Cancer

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.

Eligibility

Sex: FEMALEMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (10)

Indiana University (Data Collection Only)

Indianapolis, Indiana, United States

Johns Hopkins Hospital (Data Collection Only)

Baltimore, Maryland, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Outcomes

Primary Outcomes

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%.

Time frame: 24 weeks

Data from ClinicalTrials.gov

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