Clinical trial NCT03988595: Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Official title: Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Hormone Receptor Positive Metastatic Breast Cancer
Keywords: Exercise
19-113
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 54
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: maximum feasible dose (MFD)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University (Data Collection Only)
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital (Data Collection Only)
state: Maryland
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Health Systems (Montefiore Medical Center) (Data Collection Only)
state: New York
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk (Limited protocol activity)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neil Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
References: