Step Count and Treatment Response in Neoadjuvant Breast Cancer

NCT07162675 | Recruiting

• 1 other identifier: AEŞH-BADEK2-2025-454
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

neoadjuvant therapy; HER2-Negative Breast Cancer; Smartwatch; Step Count; Physical Activity; Patient-Reported Outcomes; Quality of Life (EORTC QLQ-C30)

Outcome Measures

Primary Outcomes (2)

• 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.

  From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).

• 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.

  From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline (within first week of therapy) to completion of neoadjuvant therapy (24-32 weeks).

• EORTC QLQ-C30 Global Health and Functional Scales

  From baseline (within first week of neoadjuvant therapy) to completion of neoadjuvant therapy (24-32 weeks).

Other Outcomes (10)

• Device-Measured Physical Activity Intensity

  From treatment initiation to end of neoadjuvant therapy (up to 32 weeks).

• Resting Heart Rate (RHR)

  From treatment initiation to end of neoadjuvant therapy (up to 32 weeks).

• Device-Measured Sleep Duration

  From device allocation to end of neoadjuvant therapy (up to 32 weeks).

Study Arms (1)

Neoadjuvant HER2-Negative Breast Cancer Patients

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.

Device: Huawei Fit 2 Smartwatch

Interventions

Huawei Fit 2 Smartwatch DEVICE

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.

Neoadjuvant HER2-Negative Breast Cancer Patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only biologically female patients with pathologically confirmed non-metastatic HER2-negative breast cancer are eligible for participation.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (2)

Etlik City Hospital, Medical Oncology Department

Ankara, Yenimahalle, 06210, Turkey (Türkiye)

RECRUITING

Gazi University Medical Oncology Department

Ankara, Çankaya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Motor Activity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Galip Can Uyar, MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

• Orhun Akdoğan, MD

  Gazi University Medical Oncology Departmant, Ankara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Galip Can Uyar, MD

CONTACT

+905065963812; g.can_uyar@hotmail.com

Ömür Berna Öksüzoğlu, MD

CONTACT

+905055718475; bernaoksuzoglu@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 9, 2025
• Study Start: September 8, 2025
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)