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Step Count and Treatment Response in Neoadjuvant Breast Cancer

Study acronym: NEOBRE-STEP
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date changed from estimate of Aug 29, 2026 to Oct 6, 2026 Show 4 more changesShow less
    • Study completion pushed from Aug 29, 2026 to Feb 15, 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
  2. Primary completion date: Dec 29, 2025 to Aug 29, 2026
    • Study completion date: Mar 29, 2026 to Aug 29, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 30, 2025 to Sep 8, 2025
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07162675
Lead Sponsor Ankara Etlik City Hospital
Conditions
(from sponsor)		 Breast Neoplasm Malignant Female, Exercise, Breast Cancer Females, Wearable Technology, Sleep Quality, Smartwatches
Related terms Motor Activity, Sleep Initiation and Maintenance Disorders
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov