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

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

ClinicalTrials.gov IDNCT07389408

PhaseNot Applicable

Enrollment2000

SponsorNational and Kapodistrian University of Athens

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer, Breast Adenocarcinoma

About this study

Primary outcomes

Distant relapse free survival (DRFS) (5- and 10-years)
Overall Survival (OS) (5- and 10-years)
Distant relapse free interval (DRFI) (5- and 10-years)
Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score (Up to 2 months post-operatively)

Eligibility information

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.

Study locations

"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

Showing 10 of 13 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-19.