NCT07216495 Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC
| NCT ID | NCT07216495 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Aerobic Exercise |
| Study Type | INTERVENTIONAL |
| Enrollment | 33 participants |
| Start Date | 2026-02-23 |
| Primary Completion | 2028-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 33 participants in total. It began in 2026-02-23 with a primary completion date of 2028-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria 1. female and male participants 18 years or older and willing to provide Informed Consent 2. clinical stage 2 or 3 TNBC (estrogen receptor and progesterone receptor ≤ 10% by immunohistochemistry (IHC) and human epidermal growth factor-2 (HER2) negative (IHC 0, IHC1+, or IHC 2+ with negative fluorescence in situ hybridization)) 3. Physically able to walk independently without assistive device and able to march in place for 30 seconds without assistive device 4. Eastern Co-Operative Oncology Group (ECOG) Performance Status 0-1 5. Planned receipt of neoadjuvant chemoICI therapy (carboplatin/taxane in combination with pembrolizumab; taxane options are weekly paclitaxel or every 3 week docetaxel) 6. clearance to participate in the study by the patient's medical oncologist 7. normal bone marrow function 8. able to read/complete study forms/assessments and understand instructions in English Exclusion criteria: a) Any physical condition which hinders the ability to safely participate in exercise including: uncontrolled or symptomatic cardiac/respiratory disease (e.g. uncontrolled angina, unusual shortness of breath, congestive heart failure, symptomatic peripheral vascular disease), stroke/myocardial infarction in the past year, fragility fracture, recent or planned orthopedic surgery, or any comorbid condition precluding exercise per the treating physician b) receipt of medications known to influence immune function including corticosteroids (\>10 mg prednisone equivalent), other immune-suppressive medication, or beta blockers47 c) Any infection or vaccination within the last 4 weeks d) e) Known HIV-positive participants on combination antiretroviral therapy f) concurrent participation in a therapeutic clinical trial or other exercise program g) pregnant h) medically advised to not exercise i) Unable to walk on a motor-driven treadmill for \~30 minutes at study enrollment j) Adults unable to consent k) No external catheters/drains (e.g., nephrostomy tube, foley catheter). A colostomy or Ileostomy is acceptable. l) Prior or concurrent non-breast malignancy. Those with prior cancers treated with curative intent are eligible. Participants with known (or history) of hepatitis B positive, or hepatitis C positive infection
Contact & Investigator
Jasmine Sukumar, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT07216495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aerobic Exercise. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216495 currently recruiting?
Yes, NCT07216495 is actively recruiting participants. Contact the research team at SYFoster@mdanderson.org for enrollment information.
Where is the NCT07216495 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07216495 clinical trial?
NCT07216495 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Jasmine Sukumar, MD at M.D. Anderson Cancer Center. The trial plans to enroll 33 participants.