Aerobic exercise during immune checkpoint inhibitor therapy for early-stage triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.