Step Count and Treatment Response in Neoadjuvant Breast Cancer
Recruiting · NCT07162675 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ankara Etlik City Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
2 locations listed.
- Etlik City Hospital, Medical Oncology Department - Ankara, Yenimahalle, Turkey (Türkiye)
- Gazi University Medical Oncology Department - Ankara, Çankaya, Turkey (Türkiye)