Actively Recruiting
Step Count and Treatment Response in Neoadjuvant Breast Cancer
Led by Ankara Etlik City Hospital · Updated on 2026-02-20
82
Participants Needed
2
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.
CONDITIONS
Official Title
Step Count and Treatment Response in Neoadjuvant Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Pathologically confirmed non-metastatic HER2-negative breast cancer
- Scheduled to receive neoadjuvant systemic therapy followed by surgery
- ECOG performance status 0 to 2
- Ability to provide informed consent
You will not qualify if you...
- Metastatic breast cancer at diagnosis
- HER2-positive breast cancer
- Previous systemic therapy for current breast cancer
- Severe comorbidities limiting mobility or physical activity (e.g., advanced neurologic or musculoskeletal disorders)
- ECOG performance status 3 or higher
- Pregnancy or breastfeeding
- Refusal or inability to use a smartwatch device
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06210
Actively Recruiting
2
Gazi University Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)
Actively Recruiting
Research Team
G
Galip Can Uyar, MD
CONTACT
Ö
Ömür Berna Öksüzoğlu, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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