NCT07162675 Step Count and Treatment Response in Neoadjuvant Breast Cancer
| NCT ID | NCT07162675 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara Etlik City Hospital |
| Condition | Breast Neoplasm Malignant Female |
| Study Type | OBSERVATIONAL |
| Enrollment | 82 participants |
| Start Date | 2025-09-08 |
| Primary Completion | 2026-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 82 participants in total. It began in 2025-09-08 with a primary completion date of 2026-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Galip Can Uyar, MD
PRINCIPAL INVESTIGATOR
Ankara Etlik City Hospital
Frequently Asked Questions
Who can join the NCT07162675 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm Malignant Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07162675 currently recruiting?
Yes, NCT07162675 is actively recruiting participants. Contact the research team at g.can_uyar@hotmail.com for enrollment information.
Where is the NCT07162675 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye), Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07162675 clinical trial?
NCT07162675 is sponsored by Ankara Etlik City Hospital. The principal investigator is Galip Can Uyar, MD at Ankara Etlik City Hospital. The trial plans to enroll 82 participants.