Actively Recruiting
Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC
Led by M.D. Anderson Cancer Center · Updated on 2026-04-15
33
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female and male participants 18 years or older and willing to provide informed consent
- Clinical stage 2 or 3 Triple Negative Breast Cancer with estrogen and progesterone receptor levels 64; 10% and HER2 negative
- Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device
- Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1
- Planned receipt of neoadjuvant chemotherapy with carboplatin/taxane and pembrolizumab
- Clearance to participate by the patient's medical oncologist
- Normal bone marrow function
- Able to read and complete study forms and understand instructions in English
You will not qualify if you...
- Any physical condition hindering safe participation in exercise, including uncontrolled or symptomatic cardiac or respiratory disease, recent stroke or myocardial infarction, fragility fracture, recent or planned orthopedic surgery, or other comorbid conditions precluding exercise
- Use of medications affecting immune function such as corticosteroids (>10 mg prednisone equivalent), immune-suppressive drugs, or beta blockers
- Infection or vaccination within the last 4 weeks
- Known HIV-positive on combination antiretroviral therapy
- Concurrent participation in another therapeutic clinical trial or exercise program
- Pregnant individuals
- Medically advised not to exercise
- Unable to walk on a motor-driven treadmill for approximately 30 minutes at enrollment
- Adults unable to consent
- Presence of external catheters or drains except colostomy or ileostomy
- Prior or concurrent non-breast malignancy except those treated with curative intent
- Known or history of hepatitis B or C infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Salma Foster
CONTACT
L
Livia Geoffrey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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