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.
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.
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).
The study population will consist of eighty-two female patients with non-metastatic, HER2-negative breast cancer who are scheduled to receive neoadjuvant systemic therapy followed by surgery. All participants will be recruited consecutively from the Department of Medical Oncology at Ankara Etlik City Hospital and Gazi University Faculty of Medicine.
Cohort
Prospective
Huawei Fit 2 Smartwatch
DeviceParticipants 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.
Pathological Complete Response (pCR)
Defined as the absence of residual invasive carcinoma in the breast and axillary lymph nodes at surgery. Pathological response will be evaluated after completion of neoadjuvant systemic therapy.
Miller-Payne Tumor Regression Score
Histopathological regression grading system ranging from 1 (minimal regression) to 5 (complete disappearance of invasive cancer). Higher scores indicate greater regression.
Pittsburgh Sleep Quality Index (PSQI) Score
Patient-reported questionnaire assessing global sleep quality. Score range: 0-21; higher scores indicate worse sleep quality. A cut-off \>5 defines poor sleep quality. A validated Turkish version is available.
EORTC QLQ-C30 Global Health and Functional Scales
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Scores standardized to 0-100. Higher scores on functional scales represent better functioning; higher scores on symptom scales represent worse symptom burden. A validated Turkish version is available.
Device-Measured Physical Activity Intensity
Minutes per day spent in moderate-to-vigorous physical activity, including bouts ≥10 minutes, measured by smartwatch.
Resting Heart Rate (RHR)
Average weekly resting heart rate measured by smartwatch (beats per minute). Changes from baseline will be evaluated.
Device-Measured Sleep Duration
Nightly sleep duration derived from smartwatch recordings, measured in hours per night.
Device-Measured Sleep Efficiency
Proportion of time asleep relative to time in bed, derived from smartwatch recordings, expressed as percentage (%).
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