A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Greece
Elena Venizelou General Hospital, Department of Surgery
RECRUITING
Athens
Henry Dunant Hospital Center, 3rd Breast Surgical Department
RECRUITING
Athens
Laiko Hospital, National and Kapodistrian University of Athens, Medical School
RECRUITING
Athens
Mediterraneo Hospital, Breast Clinic
RECRUITING
Athens
Prolipsis Center, Breast Unit
RECRUITING
Athens
Metropolitan General Hospital, 3rd Breast Clinic
RECRUITING
Cholargós
Metropolitan General Hospital, 4th Breast Clinic
RECRUITING
Cholargós
Apollonio-Theotokos General Clinic, Department of Surgery
RECRUITING
Larissa
IASO Thessalias General Clinic, Breast Surgery Department
RECRUITING
Larissa
IASO General Clinic, 2nd Breast Clinic
RECRUITING
Marousi
MITERA, 1st Breast Clinic
RECRUITING
Marousi
Thessaloniki Bioclinic Hospital, Breast Unit
RECRUITING
Thessaloniki
General Hospital of Trikala, Breast Surfery Dept.
RECRUITING
Trikala
Contact Information
Primary
Michalis Kontos
michalis_kontos@yahoo.com
+30 2132060800
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2038-12-31
Participants
Target number of participants: 2000
Treatments
Non-metastatic breast cancer N0-N1 patients eligible for EndoPredict testing
Subjects diagnosed with non-metastatic invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing. No intervention is planned, as this is an observational study and treatment of patients will not be changed due to their participation in the study.
Related Therapeutic Areas
Sponsors
Leads: National and Kapodistrian University of Athens