Clinical Trial

Step Count and Treatment Response in Neoadjuvant Breast Cancer

Study acronym: NEOBRE-STEP

Recruiting

Summary

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.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2025-09-07; most recent amendment 2026-02-19.

Status change: Not Yet Recruiting → Recruiting 2025-09-08

Trial Details

NCT Number	NCT07162675
Lead Sponsor	Ankara Etlik City Hospital
Conditions	Breast Neoplasm Malignant Female, Exercise, Breast Cancer Females, Wearable Technology, Sleep Quality, Smartwatches
Enrollment	82 participants
Start Date	2025-09-08
Primary Completion	2026-08-29 (estimated)
Study Completion	2026-08-29 (estimated)
Updated on ClinicalTrials.gov	2026-02-20