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Step Count and Treatment Response in Neoadjuvant Breast Cancer

NCT07162675 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 82

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm Malignant Female
  • Exercise
  • Breast Cancer Females
  • Wearable Technology
  • Sleep Quality
  • Smartwatches

Interventions

DEVICE

Huawei Fit 2 Smartwatch

Participants will receive a Huawei Fit 2 smartwatch within the first week of initiating neoadjuvant systemic therapy. The device will be worn throughout the treatment period to continuously monitor step counts, physical activity intensity, sleep duration, and heart rate. It is used solely for non-invasive monitoring and does not alter the standard oncological treatment.

Sponsors & Collaborators

  • Ankara Etlik City Hospital

    lead OTHER_GOV

Principal Investigators

  • Galip Can Uyar, MD · Ankara Etlik City Hospital

  • Orhun Akdoğan, MD · Gazi University Medical Oncology Departmant, Ankara

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-08
Primary Completion
2026-08-29
Completion
2026-08-29

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162675 on ClinicalTrials.gov