Hormone Receptor Positive Metastatic Breast Cancer
Conditions
Keywords
Exercise, 19-113
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.
Interventions
OTHERExercise Treatment
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Exercise therapy will consist of individualized walking delivered 3 to 5 times weekly for 24 weeks. This trial will evaluate four escalated doses of exercise (90 mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/week, or 375 mins/week).
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum feasible dose (MFD) | 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%. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed