Step Count and Treatment Response in Neoadjuvant Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Pathological Complete Response (pCR) — From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).
  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 — From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).
  Histopathological regression grading system ranging from 1 (minimal regression) to 5 (complete disappearance of invasive cancer). Higher scores indicate greater regression.

Trial sites (2)

More Ankara Etlik City Hospital trials in Turkey

Other trials for the same condition