Pilot Study of Aerobic Exercise During Immune Checkpoint Inhibitor Therapy in Early-Stage TNBC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise.
- Who it may be relevant to
- Registry conditions: Aerobic Exercise, Early Stage Triple Negative Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer
Overview
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.
Detailed description
Primary Objective To evaluate the feasibility of a supervised cardiorespiratory exercise program in patients with clinical stage 2-3 Triple Negative Breast Cancer (TNBC) undergoing neoadjuvant chemotherapy with immune checkpoint inhibitor therapy.
Secondary Objectives To explore the relationship between cardiorespiratory exercise and circulating immune (CD8+ T) cells in the peripheral blood.
Interventions
- Other Exercise
Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.
Primary outcome measures
- Adherence [Time frame: Approximately 8 weeks]
Secondary outcome measures (1)
- Circulating immune (CD8+ T) cells in the peripheral blood [Time frame: Approximately 8 weeks]
Eligibility criteria
Inclusion criteria
- female and male participants 18 years or older and willing to provide Informed Consent
- 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))
- 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 chemoICI therapy (carboplatin/taxane in combination with pembrolizumab; taxane options are weekly paclitaxel or every 3 week docetaxel)
- clearance to participate in the study by the patient's medical oncologist
- normal bone marrow function
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT07216495 · 2025-1303 · NCI-2025-07495