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RecruitingNCT07389408

A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing

Sponsor

National and Kapodistrian University of Athens

Enrollment

2,000 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

Breast CancerBreast Adenocarcinoma

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

Min Age: 18 Years

Inclusion Criteria7

  • Age ≥ 18 years old.
  • Histological diagnosis of invasive breast cancer.
  • T1-T3 tumor size.
  • 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 Criteria3

  • 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.

Locations(13)

"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

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NCT07389408

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