Daily step counts and treatment response in early HER2‑negative 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
This project will try to see if daily step counts from a Huawei smartwatch can predict how well people with non-metastatic HER2‑negative breast cancer respond to chemotherapy given before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 2 sites (Ankara, Yenimahalle and 1 other locations) |
| Trial ID | NCT07162675 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational cohort that will enroll 82 women with non-metastatic HER2‑negative breast cancer scheduled for neoadjuvant systemic therapy followed by surgery. Participants will wear Huawei Fit 2 smartwatches continuously to record step counts, activity intensity, sleep, and heart rate while questionnaires on sleep quality and quality of life are collected at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller‑Payne score; secondary outcomes include sleep quality (PSQI), EORTC QLQ‑C30 quality of life measures, perioperative outcomes, and feasibility/adherence to smartwatch monitoring. Analyses will look for associations between digital activity metrics and pathological response to neoadjuvant therapy.
Who should consider this trial
Good fit: Women aged 18 or older with pathologically confirmed non‑metastatic HER2‑negative breast cancer who are scheduled for neoadjuvant systemic therapy, have ECOG performance status 0–2, and can use a smartwatch are ideal candidates.
Not a fit: Patients with metastatic or HER2‑positive disease, prior systemic therapy for the current cancer, severe mobility‑limiting comorbidities, or inability/refusal to use a smartwatch are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, passive smartwatch monitoring could help identify patients more or less likely to achieve complete pathological response and support personalized supportive care during treatment.
How similar studies have performed: Previous research has shown wearables can feasibly track activity and that higher activity often correlates with better cancer outcomes, but using step counts specifically to predict pathological complete response in neoadjuvant breast cancer is largely novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ankara, Yenimahalle and 1 other locations
- Etlik City Hospital, Medical Oncology Department — Ankara, Yenimahalle, Turkey (Türkiye) (Recruiting)
- Gazi University Medical Oncology Department — Ankara, Çankaya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Galip Can Uyar, MD — Ankara Etlik City Hospital
- Study coordinator: Galip Can Uyar, MD
- Email: g.can_uyar@hotmail.com
- Phone: +905065963812
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.