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.
Brief Title
Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Hormone Receptor Positive Metastatic Breast Cancer
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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Keywords
Exercise
19-113
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
19 Years
NCT Id
NCT03988595
Org Class
Other
Org Full Name
Memorial Sloan Kettering Cancer Center
Org Study Id
19-113
Overall Status
Active, not recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
Primary Outcomes
Outcome Description
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%.
Outcome Measure
maximum feasible dose (MFD)
Outcome Time Frame
24 weeks
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
19
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jesus Anampa Mesias
Investigator Email
janampa@montefiore.org
Investigator Phone
718-920-4826/718-405-8505/646-757-0997