NCT07216495

Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC

Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if participating in a supervised exercise program can help participants with early-stage TNBC who are receiving ICI therapy before undergoing breast surgery.

Detailed description

Primary Objective To evaluate the feasibility of a supervised cardiorespiratory exercise program in patients with clinical stage 2-3 Triple Negative Breast Cancer (TNBC) undergoing neoadjuvant chemotherapy with immune checkpoint inhibitor therapy. Secondary Objectives To explore the relationship between cardiorespiratory exercise and circulating immune (CD8+ T) cells in the peripheral blood.

Conditions

• Aerobic Exercise
• Early Stage Triple Negative Breast Cancer

Interventions

Type	Name	Description
OTHER	Exercise	Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.

Timeline

• Start date: 2026-02-23
• Primary completion: 2028-10-30
• Completion: 2030-10-30
• First posted: 2025-10-14
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States