RecruitingNCT07162675

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

Sponsor

Ankara Etlik City Hospital

Enrollment

82 participants

Start Date

Sep 8, 2025

Study Type

OBSERVATIONAL

Conditions

Exercise Breast Cancer Females Breast Neoplasm Malignant Female Wearable Technology Sleep Quality Smartwatches

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether the number of daily steps a patient takes — measured by a smartwatch — can predict how well breast cancer responds to chemotherapy given before surgery. The researchers want to know if physical activity levels are linked to treatment outcomes. **You may be eligible if...** - You are a woman aged 18 or older - You have confirmed non-metastatic, HER2-negative breast cancer - You are scheduled to receive chemotherapy before surgery (neoadjuvant therapy) - You are in reasonably good health (ECOG 0–2) - You are willing to wear a smartwatch during the study **You may NOT be eligible if...** - Your breast cancer has spread to other parts of the body (metastatic) - Your cancer is HER2-positive - You have already had treatment for this breast cancer - You have a serious condition limiting your mobility (e.g., severe neurological or joint disease) - You are pregnant or breastfeeding - You refuse to wear a smartwatch Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHuawei 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.