This phase I trial determines the maximum amount of exercise intervention given at the same time (concurrent) as first-line therapy in treating patients with hormone receptor positive breast cancer that has spread to other places in the body (metastatic). Exercise may help delay the development of resistance to hormone therapy while slowing the growth of tumors. This study will test any good and bad effects of aerobic exercise performed while the patient is receiving the usual first-line treatment for metastatic breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03988595.
PRIMARY OBJECTIVE:
I. To determine the maximum feasible dose (MFD) of exercise treatment administered to patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer (MBC) during first line endocrine-based therapy.
SECONDARY OBJECTIVES:
I. To evaluate the biological activity of exercise characterized by changes in circulating tumor DNA (ctDNA) and tumor biology (proliferation, HR-signaling).
II. To evaluate clinical activity as assessed by quality of life (QOL) and patient reported outcome (PRO) measures.
III. To explore pharmacodynamics as evaluated by changes in physiological (e.g., exercise capacity, body weight, body composition, blood pressure) and biological (e.g., blood-based metabolic profile) correlates.
IV. To explore the dose-exposure effects of exercise on gut microbiome diversity.
V. To estimate the cumulative relative dose intensive (RDI) at 24 weeks.
OUTLINE: This is a dose-escalation study of exercise therapy.
Patients participate in an individualized exercise program consisting of walking on a treadmill for 90, 150, 225, 300, or 375 minutes per week (7 sessions per week) for 24 weeks. Patients also undergo collection of blood samples throughout the trial.
After completion of study, patients are followed up within 2 weeks.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott
