Aerobic exercise during immune checkpoint inhibitor therapy for early-stage triple-negative breast cancer
Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer
NA · M.D. Anderson Cancer Center · NCT07216495
This study will test whether a supervised aerobic exercise program helps people with early-stage triple-negative breast cancer who are receiving immune checkpoint inhibitor therapy before surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | pembrolizumab, prednisone, chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07216495 on ClinicalTrials.gov |
What this trial studies
This pilot interventional study enrolls adults with clinical stage 2–3 triple-negative breast cancer who are scheduled to receive neoadjuvant carboplatin/taxane chemotherapy combined with pembrolizumab. Participants take part in a supervised cardiorespiratory (aerobic) exercise program delivered during their preoperative chemoimmunotherapy period. The primary goal is to determine the feasibility of delivering this exercise program in this patient population, and secondary objectives include measuring changes in circulating CD8+ T cells. Clinical and laboratory measures will be collected before, during, and after the intervention to characterize safety, adherence, and immune-related signals.
Who should consider this trial
Good fit: Adults (male or female) aged 18 or older with clinical stage 2–3 triple-negative breast cancer who are planned for neoadjuvant carboplatin/taxane plus pembrolizumab, have ECOG 0–1, can walk independently and perform brief marching in place, have normal bone marrow function, can read English, and are cleared by their medical oncologist.
Not a fit: Patients with metastatic disease, poor performance status, significant physical limitations that prevent safe aerobic exercise, or those not receiving the specified neoadjuvant chemo‑ICI regimen are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could improve patients' cardiorespiratory fitness, treatment tolerance, and might enhance anti-tumor immune responses that could improve outcomes.
How similar studies have performed: Prior work shows exercise during chemotherapy is generally safe and can improve fitness and some immune markers, but specifically combining supervised aerobic training with immune checkpoint inhibitors in early-stage TNBC is a novel, largely untested approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Jasmine Sukumar, MD — M.D. Anderson Cancer Center
- Study coordinator: Salma Foster
- Email: SYFoster@mdanderson.org
- Phone: 713-794-1613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aerobic Exercise, Early Stage Triple Negative Breast Cancer