Daily step counts and treatment response in early HER2‑negative breast cancer
Official title: 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
Run by Ankara Etlik City Hospital · NCT07162675 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 82 (estimated) |
| Sponsor | Ankara Etlik City Hospital Government |
| Locations | 2 sites (Ankara, Yenimahalle and 1 other locations) |
| Status | Recruiting |
| Started | September 8, 2025 |
| Main results expected | October 6, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07162675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Physical activity habits and sleep/ breathing in obstructive sleep apnea
This study tests whether daily physical activity habits affect sleep quality and breathing measurements in people with obstructive sleep apnea who are on CPAP therapy.
-
Shoulder pain patients: see if breathing and chest exercises help pain and sleep
This study tests whether adding respiratory muscle strengthening and diaphragmatic breathing to shoulder rehab can reduce pain and improve sleep in adults with chronic shoulder pain.
-
Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes
This study tests whether using the Accu-Chek SmartGuide CGM with its Predict App can reduce fear of hypoglycemia and improve related behaviors and confidence in adults with type 1 or insulin-treated type 2 diabetes.
-
Ashwagandha with resistance training to boost strength and stress markers
This 12-week study tests whether taking ASHWAGANDHA along with regular resistance training helps healthy, trained men see improvements in strength, stress levels, sleep, and cognitive function compared with a placebo.
-
Acupoint Stimulation and Exercise for Pre-frail Older Adults in Taiwan
This study tests whether combining exercise with daytime and sleep-improving acupoint stimulation helps pre-frail adults 50 and older in Taiwan feel less frail and sleep better.
-
Sleep and Chronotype linked to Prosocial Choices
This observational study tests whether people’s sleep quality and chronotype relate to how they decide to allocate money in a hypothetical task.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.