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Step Count and Treatment Response in Neoadjuvant Breast Cancer

Recruitingn/aAges 18 Years - anyFemaleAnkara Etlik City Hospital
NCT07162675 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female patients aged ≥18 years. * Pathologically confirmed non-metastatic HER2-negative breast cancer. * Candidates scheduled to receive neoadjuvant systemic therapy followed by surgery. * ECOG performance status 0-2. * Ability to provide informed consent. Exclusion Criteria: * 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. * Pregnancy or breastfeeding. * Refusal or inability to use a smartwatch device.
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What it tests

  • Huawei Fit 2 Smartwatch
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Where

2 sites
Etlik City Hospital, Medical Oncology Department
Ankara, Turkey (Türkiye)
Gazi University Medical Oncology Department
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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