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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Salma Foster
SYFoster@mdanderson.org
713-794-1613
Backup
Livia Geoffrey
LGeoffrey@mdanderson.org
832-728-6175
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2030-10-30
Participants
Target number of participants: 33
Treatments
Experimental: Acute cardiorespiratory exercise program
consisting of 4 in-clinic exercise sessions
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov

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