Status:
RECRUITING
Step Count and Treatment Response in Neoadjuvant Breast Cancer
Lead Sponsor:
Ankara Etlik City Hospital
Conditions:
Breast Neoplasm Malignant Female
Exercise
Eligibility:
FEMALE
18+ years
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-metastati...
Detailed 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-i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 29 2026
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT07162675
Start Date
September 8 2025
End Date
March 29 2026
Last Update
September 12 2025
Active Locations (2)
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1
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye), 06210
2
Gazi University Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)