Step Count and Treatment Response in Neoadjuvant Breast Cancer (NEOBRE-STEP)

Ankara Etlik City Hospital

Status: Enrolling

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

Treatments: Device: Huawei Fit 2 Smartwatch

Study type: Observational

Funder types: Other

Identifiers

NCT07162675

AEŞH-BADEK2-2025-454 (Other Identifier)

Details and patient eligibility

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.

Full description

Physical activity and sleep quality are important prognostic factors in oncology, but objective and continuous monitoring during neoadjuvant systemic therapy is limited. Wearable devices provide non-invasive, real-time data on step counts, heart rate, and sleep. This study will evaluate whether daily step counts and digital health metrics predict pathological response in non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.

Primary Objective: To assess the association between daily step counts and pathological response, including pathological complete response (pCR, defined as no residual invasive carcinoma in the breast and axillary nodes) and Miller-Payne score (range 1-5; higher scores indicate greater regression).

Secondary Objectives: To explore associations between physical activity and sleep quality (Pittsburgh Sleep Quality Index, PSQI), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), and perioperative outcomes; and to evaluate feasibility and adherence to smartwatch monitoring.

Methods: This is a multicenter prospective observational cohort study enrolling 82 female patients aged ≥18 years with non-metastatic HER2-negative breast cancer scheduled to receive neoadjuvant systemic therapy followed by surgery. Smartwatches (Huawei Fit 2) will continuously monitor activity, sleep, and heart rate. Questionnaires will be administered at baseline and at the end of treatment.

PSQI: Global score 0-21; higher scores indicate worse sleep quality; a cut-off >5 defines poor sleep. A validated Turkish version is available.

EORTC QLQ-C30: Standardized 0-100 scoring system; higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate greater symptom burden. A validated Turkish version is available.

Pathological response will be determined at surgery using pCR and Miller-Payne criteria.

Sample Size and Statistics: A priori power analysis (effect size d = 0.5, α = 0.05, power = 0.80) indicates a minimum of 82 patients. Regression analyses and subgroup evaluations will test associations with step counts, questionnaire scores, and perioperative outcomes.

Significance: This study (NEOBRE-STEP) is among the first multicenter efforts to integrate wearable health monitoring into breast cancer supportive care. By combining objective activity and sleep data with validated patient-reported outcomes, the study may provide new prognostic insights and support the integration of digital health tools into oncology practice.

Enrollment: 82 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

82 participants in 1 patient group

Neoadjuvant HER2-Negative Breast Cancer Patients

Description:

This cohort includes female patients aged ≥18 years with non-metastatic, HER2-negative breast cancer who are scheduled to receive neoadjuvant systemic therapy followed by surgery.

Treatment:

Device: Huawei Fit 2 Smartwatch