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Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a supervised aerobic exercise program can help people with early-stage triple-negative breast cancer (TNBC). It is for people getting chemotherapy and pembrolizumab, a drug that helps the immune system fight cancer, before breast surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older, of any sex, and willing to give informed consent (agree to join after learning about the study).
  • Have stage 2 or 3 triple-negative breast cancer that meets the study’s tumor test rules.
  • Be able to walk on your own and march in place for 30 seconds without a walking aid.
  • Be fully active or able to walk and do light work, even if hard physical activity is limited.
  • Plan to get carboplatin, pembrolizumab, and either weekly paclitaxel or docetaxel every 3 weeks before surgery.
  • Have your cancer doctor’s approval to join.
  • Have normal bone marrow function, meaning your body makes blood cells normally.
  • Be able to read and fill out study forms and understand instructions in English.

Who can't join

  • Have a condition that makes exercise unsafe, or have medical advice not to exercise. Examples include certain heart or lung problems, a stroke or heart attack in the past year, a bone break from weak bones, or recent or planned bone or joint surgery. You also cannot join if you cannot walk on a powered treadmill for about 30 minutes at enrollment.
  • Take medicines that affect the immune system, including steroids above a dose equal to 10 mg of prednisone, other immune-suppressing drugs, or beta blockers.
  • Have had an infection or vaccine in the past 4 weeks, or have current or past hepatitis B or C infection.
  • Have HIV and take a combination of medicines to treat it.
  • Be in another treatment trial or exercise program.
  • Be pregnant or unable to give informed consent.
  • Have a tube outside the body that drains urine or other fluid. A colostomy or ileostomy, an opening in the belly for waste, is allowed.
  • Have a past or current cancer other than breast cancer. Past cancers treated with the goal of curing them are allowed.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX