Hormone Receptor Positive Metastatic Breast Cancer Clinical Trial
Official title:
Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
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.
| Status | Recruiting |
| Enrollment | 53 |
| Est. completion date | August 1, 2024 |
| Est. primary completion date | August 1, 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only) | Bronx | New York |
| United States | Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity) | Commack | New York |
| United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
| United States | Indiana University (Data Collection Only) | Indianapolis | Indiana |
| United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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%. | 24 weeks |