RECRUITINGOBSERVATIONAL

Step Count and Treatment Response in Neoadjuvant Breast Cancer

A Multicenter Prospective Study: The Impact of Step Count Measured by Smartwatches on Treatment Response in Non-Metastatic HER2-Negative Breast Cancer Patients Receiving Neoadjuvant Therapy

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Female patients aged ≥18 years. - Pathologically confirmed non-metastatic HER2-negative breast cancer. - Candidates scheduled to receive neoadjuvant systemic therapy followed by surgery. - You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2. - Ability to provide willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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.

Locations (2)

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, Turkey (Türkiye)

Gazi University Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)