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

Not Applicable

Not yet recruiting

• Conditions: Aerobic Exercise; Early Stage Triple Negative Breast Cancer

• Registration Number: NCT07216495
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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 participants 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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-10
• Study First Submitted QC: 2025-10-10
• Study First Posted: 2025-10-14
• Last Update Submitted: 2025-10-23
• Last Update Posted: 2025-10-24
• Study Start: 2026-04-06
• Primary Completion: 2028-10-30
• Study Completion: 2030-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and adverse events (AEs)	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States