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

NCT07216495 | Recruiting DMC

• 2 other identifiers: 2025-1303NCI-2025-07495
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aerobic Exercise; Early Stage Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Adherence

  Feasibility will be measured by adherence to both exercise frequency and time (duration/intensity) at the supervised sessions.

  Approximately 8 weeks

Secondary Outcomes (1)

• Circulating immune (CD8+ T) cells in the peripheral blood

  Approximately 8 weeks

Other Outcomes (12)

• Other blood-based circulating immune cells pre-, during-, and post-exercise

  Approximately 8 weeks

• VO2 peak/max

  Approximately 8 weeks

• European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (general cancer)

  Approximately 8 weeks

Study Arms (1)

Acute cardiorespiratory exercise program

EXPERIMENTAL

consisting of 4 in-clinic exercise sessions

Other: Exercise

Interventions

Exercise OTHER

Cardiorespiratory training via treadmill walking for 30 minutes; participants will be supervised by a trained exercise physiologist.

Acute cardiorespiratory exercise program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jasmine Sukumar, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salma Foster

CONTACT

713-794-1613; SYFoster@mdanderson.org

Livia Geoffrey

CONTACT

832-728-6175; LGeoffrey@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2025
• First Posted: October 14, 2025
• Study Start: February 23, 2026
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): October 30, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)