Breast Neoplasm Malignant FemaleNEOBRE-STEPNCT07162675
Step Count and Treatment Response in Neoadjuvant Breast Cancer
An observational study of Breast Neoplasm Malignant Female and Exercise, run by Ankara Etlik City Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Malignant Female, Exercise, Breast Cancer Females
- What is being tested?
- Huawei Fit 2 Smartwatch
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 8 Sep 2025to 15 Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, 06210
Galip Can Uyar, MD, +905065963812, g.can_uyar@hotmail.com
Ömür Berna Öksüzoğlu, MD, sutcuogluo@gmail.com
- Recruiting
Gazi University Medical Oncology Department
Ankara, Çankaya
Orhun Akdoğan, MD, +905375831594, orhunakdogan@gmail.com
Osman Sütcüoğlu, MD, +905376679724, sutcuogluo@gmail.com
About this study
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
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.
Read the 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-invasive, real-time data on step counts, heart rate, and sleep. This study will evaluate whether daily step counts and digital health metrics predict pathological response in non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.
Primary Objective: To assess the association between daily step counts and pathological response, including pathological complete response (pCR, defined as no residual invasive carcinoma in the breast and axillary nodes) and Miller-Payne score (range 1-5; higher scores indicate greater regression).
Secondary Objectives: To explore associations between physical activity and sleep quality (Pittsburgh Sleep Quality Index, PSQI), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), and perioperative outcomes; and to evaluate feasibility and adherence to smartwatch monitoring.
Methods: This is a multicenter prospective observational cohort study enrolling 82 female patients aged ≥18 years with non-metastatic HER2-negative breast cancer scheduled to receive neoadjuvant systemic therapy followed by surgery. Smartwatches (Huawei Fit 2) will continuously monitor activity, sleep, and heart rate. Questionnaires will be administered at baseline and at the end of treatment.
PSQI: Global score 0-21; higher scores indicate worse sleep quality; a cut-off >5 defines poor sleep. A validated Turkish version is available.
EORTC QLQ-C30: Standardized 0-100 scoring system; higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate greater symptom burden. A validated Turkish version is available.
Pathological response will be determined at surgery using pCR and Miller-Payne criteria.
Sample Size and Statistics: A priori power analysis (effect size d = 0.5, α = 0.05, power = 0.80) indicates a minimum of 82 patients. Regression analyses and subgroup evaluations will test associations with step counts, questionnaire scores, and perioperative outcomes.
Significance: This study (NEOBRE-STEP) is among the first multicenter efforts to integrate wearable health monitoring into breast cancer supportive care. By combining objective activity and sleep data with validated patient-reported outcomes, the study may provide new prognostic insights and support the integration of digital health tools into oncology practice.
- Conditions
- Breast Neoplasm Malignant Female, Exercise, Breast Cancer Females, Wearable Technology, Sleep Quality, Smartwatches
- Being tested
- Huawei Fit 2 Smartwatch
- Keywords
- neoadjuvant therapy, HER2-Negative Breast Cancer, Smartwatch, Step Count, Physical Activity, Patient-Reported Outcomes, Quality of Life (EORTC QLQ-C30)
- Medical subject headings
- Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huawei Fit 2 SmartwatchDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Huawei Fit 2 Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Patient-reported questionnaire assessing global sleep quality. Score range: 0-21; higher scores indicate worse sleep quality. A cut-off >5 defines poor sleep quality. A validated Turkish version is available.
Measured: Baseline (within first week of therapy) to completion of neoadjuvant therapy (24-32 weeks).
EORTC QLQ-C30 Global Health and Functional Scales
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Scores standardized to 0-100. Higher scores on functional scales represent better functioning; higher scores on symptom scales represent worse symptom burden. A validated Turkish version is available.
Measured: From baseline (within first week of neoadjuvant therapy) to completion of neoadjuvant therapy (24-32 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start8 Sep 2025
- Primary completion6 Oct 2026
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm Malignant FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Galip Can Uyar, Ankara Etlik City Hospital
- Investigators
- Galip Can Uyar, MD, Principal investigator, Ankara Etlik City HospitalOrhun Akdoğan, MD, Principal investigator, Gazi University Medical Oncology Departmant, Ankara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162675
- Sponsor's protocol ID
- AEŞH-BADEK2-2025-454
- Other IDs
- AEŞH-BADEK2-2025-454
- Acronym
- NEOBRE-STEP
- Status last verified
- Oct 2026
- First submitted
- 24 Aug 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No