Clinical trial · Interventional
Exercise Treatment With Standard Therapy for Metastatic Breast Cancer
Phase 1 Trial of Exercise Treatment With Concurrent First-Line Therapy for Hormone Receptor Positive Metastatic Breast Cancer
NCT03988595CI-TRIAL-00124748active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- aerobic training 90 mins/wk
- description
- 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.
- interventionNames
- Other: Exercise Treatment
- type
- EXPERIMENTAL
- label
- aerobic training 150 mins/wk
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.