Actively Recruiting
A Prospective, Multicenter Registry to Observe Treatment Patterns, Clinical Outcomes, and Decision-Making in Early Breast Cancer Eligible for EndoPredict4 Testing
Led by National and Kapodistrian University of Athens · Updated on 2026-02-05
2000
Participants Needed
13
Research Sites
561 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing and documenting treatment decisions, protocols, and clinical outcomes in patients with luminal (ER-positive/HER2-negative) early breast cancer who are eligible for EndoPredict4 testing. This prospective, multicenter, non-interventional registry includes patients who undergo EndoPredict testing and those who do not, aiming to understand real-world treatment patterns and long-term results. Participants have non-metastatic invasive breast cancer with tumor size T1 to T3 and 0 to 3 positive axillary lymph nodes. This observational study does not change patient treatment. Patients may enroll after surgery and before starting adjuvant endocrine therapy. The registry is conducted across multiple sites, mainly in Greece, with plans to enroll up to 2,000 participants over 3 years. Participants will be followed once yearly for up to 10 years after surgery. Researchers will collect data on clinical outcomes such as distant relapse-free survival, overall survival, and local relapse-free survival at 5 and 10 years. They will also evaluate how EndoPredict risk scores relate to treatment decisions and outcomes, alongside patient and disease characteristics influencing therapy choices.
CONDITIONS
Brief Title
A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological diagnosis of invasive breast cancer
- Tumor size T1 to T3
- 0 to 3 positive axillary lymph nodes
- ER-positive tumor confirmed by immunohistochemistry (≥1% or Allred Score ≥3/8 or H-score ≥50/300)
- HER2-negative tumor confirmed by immunohistochemistry and/or in situ hybridization
- Signed and dated informed consent form
You will not qualify if you...
- History of another primary cancer within the last 5 years, except for successfully treated non-melanoma skin cancer
- Received chemotherapy before surgery
- No signed and dated informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 years after surgery
Participants who underwent surgery are observed and followed prospectively to assess treatment patterns, clinical outcomes, and decision-making in early breast cancer.
Annual visits for up to 10 years
Trial Site Locations
Total: 13 locations
1
"Elena Venizelou" General Hospital, Department of Surgery
Athens, Greece
Actively Recruiting
2
"Prolipsis" Center, Breast Unit
Athens, Greece
Actively Recruiting
3
Henry Dunant Hospital Center, 3rd Breast Surgical Department
Athens, Greece
Actively Recruiting
4
Laiko Hospital, National and Kapodistrian University of Athens, Medical School
Athens, Greece
Actively Recruiting
5
Mediterraneo Hospital, Breast Clinic
Athens, Greece
Actively Recruiting
6
Metropolitan General Hospital, 3rd Breast Clinic
Cholargós, Greece
Actively Recruiting
7
Metropolitan General Hospital, 4th Breast Clinic
Cholargós, Greece
Actively Recruiting
8
"Apollonio-Theotokos" General Clinic, Department of Surgery
Larissa, Greece
Actively Recruiting
9
IASO Thessalias General Clinic, Breast Surgery Department
Larissa, Greece
Actively Recruiting
10
IASO General Clinic, 2nd Breast Clinic
Marousi, Greece
Actively Recruiting
11
MITERA, 1st Breast Clinic
Marousi, Greece
Actively Recruiting
12
Thessaloniki Bioclinic Hospital, Breast Unit
Thessaloniki, Greece
Actively Recruiting
13
General Hospital of Trikala, Breast Surfery Dept.
Trikala, Greece
Actively Recruiting
Research Team
M
Michalis Kontos
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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