RecruitingFemale onlyEN originalBreast cancerEarly / localized

Step Count and Treatment Response in Neoadjuvant Breast Cancer

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobiety w wieku 18 lat i starsze
  • Rak piersi potwierdzony badaniem patologicznym, bez przerzutów do innych narządów
  • Leczenie chemioterapią przed operacją, a następnie operacja chirurgiczna
  • Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (skala ECOG 0-2)
  • Świadoma zgoda na uczestnictwo w badaniu

✗ Disqualifies

  • Rak piersi z przerzutami do innych narządów
  • Rak piersi HER2-dodatni
  • Poprzednie leczenie systemowe tego samego raka piersi
  • Poważne schorzenia ograniczające mobilność (np. zaburzenia neurologiczne lub kostno-stawowe)
  • Ciąża lub karmienie piersią
  • Brak możliwości lub chęci używania urządzenia do monitorowania (smartwatch)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
February 20, 2026
Sex
Female only

Therapies / drugs in trial

Locations (2)

Etlik City Hospital, Medical Oncology Department

Ankara, Turkey (Türkiye)

Gazi University Medical Oncology Department

Ankara, Turkey (Türkiye)

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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