An interventional study of Exercise in Aerobic Exercise and Early Stage Triple Negative Breast Cancer, sponsored by M.D. Anderson Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
consisting of 4 in-clinic exercise sessions
Other: Exercise
Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.
Adherence
Feasibility will be measured by adherence to both exercise frequency and time (duration/intensity) at the supervised sessions.
Time frame: Approximately 8 weeks
Circulating immune (CD8+ T) cells in the peripheral blood
Change of CD8+ T cells in the peripheral blood from baseline (pre-exercise) to post-exercise state
Time frame: Approximately 8 weeks
Other blood-based circulating immune cells pre-, during-, and post-exercise
NK cells, T regulatory (Treg) cells, markers of T cell exhaustion and immunosenescence (CD57, CD45-RA, PD1, KLRG1, CTLA-4)
Time frame: Approximately 8 weeks
VO2 peak/max
peak oxygen uptake
Time frame: Approximately 8 weeks
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (general cancer)
This is a Patient-Reported Outcome to measure health-related quality of life in patients with cancer. The instrument consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), one global health status/quality of life scale, three multi-item symptom scales (fatigue, pain, nausea/vomiting), and several single-item symptom measures (e.g., dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).Responses are scored and transfored to a 0-100 scale. Responses are scored and linearly transformed to a 0-100 scale. For functional scales and the global health status/quality of life scale, higher scores indicate better functioning or quality of life. For symptom scales and single-item measures, higher scores indicate greater symptom severity or burden.
Time frame: Approximately 8 weeks
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR42 (breast-specific module)
This is a Patient-Reported Outcome to measure of quality of life patients with breast cancer. The instrument includes multi-item and single-item scales assessing domains such as systemic therapy side effects, breast and arm symptoms, body image, sexual functioning, sexual enjoyment, future perspective, and treatment-related symptoms. Scores are linearly transformed to a 0-100 scale. For functional scales (e.g., body image, sexual functioning, future perspective), higher scores indicate better functioning. For symptom scales/items (e.g., breast symptoms, systemic therapy side effects), higher scores indicate greater symptom burden or severity.
Time frame: Approximately 8 weeks
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-FA12
This is a Patient-Reported Outcome of multidimensional fatigue in patients with cancer. The instrument consists of 12 items evaluating physical fatigue, emotional fatigue, and cognitive fatigue, as well as the extent to which fatigue interferes with daily activities and social functioning. Responses are scored and linearly transformed to a 0-100 scale. Higher scores indicate greater fatigue severity and greater interference with functioning.
Time frame: Approximately 8 weeks
Breast surgical outcome
Pathologic complete response (pCR) rate
Time frame: Approximately 6 months
Safety of chemotherapy and ICI therapy
Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0)
Time frame: Approximately 8 weeks
Activity Tracker Data from home walking program: heart rate
heart rate in beats per minute
Time frame: Approximately 6 months
Activity Tracker Data from home walking program: step counts
steps per day
Time frame: Approximately 6 months
Data from home walking program: active/sedentary time
number of active versus sedentary minutes per day
Time frame: Approximately 6 months
Godin Leisure Time Physical Activity Questionnaire
This is a self-administered instrument used to quantify frequency of leisure time physical activity during a typical 7-day period. Participants report the number of times per week they engage in activities lasting ≥15 minutes at three intensity levels: strenuous (vigorous), moderate, and light (mild). A Leisure Score Index (LSI) will be calculated using the formula: (9 × number of strenuous sessions) + (5 × number of moderate sessions) + (3 × number of light sessions). Scores reflect weighted weekly leisure-time physical activity, with higher scores indicating greater self-reported activity levels. There is no absolute maximum score; a score of 0 indicates no reported leisure-time physical activity.
Time frame: Approximately 8 weeks
Short Physical Performance Battery (SPPB)
Measure of functional mobility (balance, lower extremity strength, and functional capacity) through assessment of 3 components (balance test, gait speed test, and chair stand test). Each component is scored from 0-4 points, for a total score range of 0-12. Higher scores indicate better functional mobility.
Time frame: Approximately 8 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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M.D. Anderson Cancer Center