A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
Recruiting · NCT07389408 · Observational (researchers observe without assigning treatment) · Lead sponsor: National and Kapodistrian University of Athens
View the official record on ClinicalTrials.gov →What this trial is about
The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years old.
- Histological diagnosis of invasive breast cancer.
- T1-T3 tumor size.
- 0-3 positive axillary lymph nodes.
- Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3/8 or H-score: ≥50/ 300)
- Documented HER2-negative tumor by immunohistochemistry and/or in situ hybridization
- Subject with signed and dated informed consent form.
Exclusion criteria
- History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.
- Pre-operative chemotherapy administered.
- Subject without signed and dated informed consent form.
Where it is running
13 locations listed.
- "Elena Venizelou" General Hospital, Department of Surgery - Athens, Greece
- "Prolipsis" Center, Breast Unit - Athens, Greece
- Henry Dunant Hospital Center, 3rd Breast Surgical Department - Athens, Greece
- Laiko Hospital, National and Kapodistrian University of Athens, Medical School - Athens, Greece
- Mediterraneo Hospital, Breast Clinic - Athens, Greece
- Metropolitan General Hospital, 3rd Breast Clinic - Cholargós, Greece
- Metropolitan General Hospital, 4th Breast Clinic - Cholargós, Greece
- "Apollonio-Theotokos" General Clinic, Department of Surgery - Larissa, Greece
- IASO Thessalias General Clinic, Breast Surgery Department - Larissa, Greece
- IASO General Clinic, 2nd Breast Clinic - Marousi, Greece
- MITERA, 1st Breast Clinic - Marousi, Greece
- Thessaloniki Bioclinic Hospital, Breast Unit - Thessaloniki, Greece
- General Hospital of Trikala, Breast Surfery Dept. - Trikala, Greece