Exercise program for women with triple-negative breast cancer
Official title: Exercise in Regional Breast Cancer With Neoadjuvant Anthracycline- Based Chemotherapy and Immunotherapy With Checkpoint-Inhibition
Run by Technical University of Munich · NCT06672120 · Data updated 2026-11-12
This study is testing whether a special exercise program can help women aged 18 to 50 with newly diagnosed triple-negative breast cancer feel better and improve their fitness during chemotherapy and immunotherapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Technical University of Munich Academic / other |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Munich, Bavaria and 1 other locations) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | June 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | May 31, 2025 |
| Trial ID | NCT06672120 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 18 to 50 with newly diagnosed, local triple-negative breast cancer (stage I-III) who are scheduled for immunotherapy and chemotherapy.
✕Probably not a fit
Patients with unstable cardiac conditions or orthopedic disabilities that prevent exercise may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of a combined aerobic exercise and resistance training program in female patients aged 18 to 50 with newly diagnosed, therapy-naive triple-negative breast cancer (TNBC) who are scheduled for chemotherapy and immunotherapy. Participants will be randomized into a control group receiving standard exercise recommendations and an intervention group engaging in a home-based, video-supervised exercise regimen over 24 weeks. The primary endpoint is the change in peak oxygen consumption (VO2peak), while secondary endpoints include physical function, cardiac biomarkers, and quality of life assessments. All patients will use smart watches for rhythm monitoring and will perform daily ECG measurements.
Why it matters
Potential benefit: If successful, this program could enhance physical fitness and quality of life for women undergoing treatment for triple-negative breast cancer.
How similar studies have gone: Other studies have shown positive outcomes with exercise interventions in cancer patients, suggesting this approach may be beneficial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 65 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy Exclusion Criteria: * Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias) * Orthopaedic disability to exercise
Where it's running
-
Preventive Sports Medicine and Sports Cardiology
Munich, Bavaria, Germany Recruiting -
Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, Germany Recruiting
Study contacts
- Principal investigator: Simon Wernhart, MD — Technical University of Munich
- Study coordinator: Martin Halle, MD
- Email: martin.halle@mri.tum.de
- Phone: +49 89-289 244 41
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.