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

January 31, 2026 updated by: Michalis Kontos, National and Kapodistrian University of Athens
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

Study Overview

Status

Recruiting

Conditions

Detailed Description

PRELUDE is a prospective, multicenter, non-interventional registry designed to describe real-world treatment decision-making, treatment patterns, and long-term clinical outcomes in patients with luminal (ER-positive/HER2-negative) early breast cancer who are eligible for EndoPredict® testing, including patients who do and do not undergo the test.

The registry will be conducted at approximately 10-20 sites across Greece (with the option to add sites outside Greece if needed) and aims to enroll up to 2,000 eligible participants within 3 years. Participants may be enrolled after surgical histopathology results are available and before commencement of adjuvant endocrine treatment, and will be followed prospectively once per year for up to 10 years after surgery.

The study aims to assess 5- and 10-year clinical outcomes and to evaluate these outcomes according to EndoPredict® (EP/EPclin) risk groups or scores among patients who undergo testing, in a real-world setting. The registry will also examine which patient and disease characteristics (e.g., age, menopausal status, nodal status, histopathology, EPclin score) will influence adjuvant treatment decisions, in the context of evolving therapeutic standards and recently introduced adjuvant options.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece
        • Recruiting
        • "Elena Venizelou" General Hospital, Department of Surgery
        • Contact:
      • Athens, Greece
      • Athens, Greece
        • Recruiting
        • Henry Dunant Hospital Center, 3rd Breast Surgical Department
        • Contact:
      • Athens, Greece
        • Recruiting
        • Laiko Hospital, National and Kapodistrian University of Athens, Medical School
        • Contact:
      • Athens, Greece
        • Recruiting
        • Mediterraneo Hospital, Breast Clinic
        • Contact:
      • Cholargós, Greece
        • Recruiting
        • Metropolitan General Hospital, 3rd Breast Clinic
        • Contact:
      • Cholargós, Greece
        • Recruiting
        • Metropolitan General Hospital, 4th Breast Clinic
        • Contact:
      • Larissa, Greece
        • Recruiting
        • "Apollonio-Theotokos" General Clinic, Department of Surgery
        • Contact:
      • Larissa, Greece
        • Recruiting
        • IASO Thessalias General Clinic, Breast Surgery Department
        • Contact:
      • Marousi, Greece
        • Recruiting
        • IASO General Clinic, 2nd Breast Clinic
        • Contact:
      • Marousi, Greece
        • Recruiting
        • MITERA, 1st Breast Clinic
        • Contact:
      • Thessaloniki, Greece
        • Recruiting
        • Thessaloniki Bioclinic Hospital, Breast Unit
        • Contact:
      • Trikala, Greece
        • Recruiting
        • General Hospital of Trikala, Breast Surfery Dept.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All subjects diagnosed with 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant relapse free survival (DRFS)
Time Frame: 5- and 10-years
To collect and evaluate distant relapse-free survival (DRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
5- and 10-years
Overall Survival (OS)
Time Frame: 5- and 10-years
To collect and evaluate overall survival (OS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
5- and 10-years
Distant relapse free interval (DRFI)
Time Frame: 5- and 10-years
To collect and evaluate distant relapse free interval (DRFI) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
5- and 10-years
Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score
Time Frame: Up to 2 months post-operatively
Proportion of participants who received adjuvant chemotherapy (yes/no) and its association with baseline clinicopathologic characteristics (age, menopausal status, nodal status, T stage, N stage, histologic grade) and EPclin score.
Up to 2 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local relapse free survival (LRFS)
Time Frame: 5- and 10-years
To collect and evaluate local relapse free survival (LRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
5- and 10-years
Performance of EndoPredict (assessed with DRFS) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women]
Time Frame: 5- and 10-years
Performance of EndoPredict in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women], assessed with distant recurrence free survival (DRFS).
5- and 10-years
Performance of EndoPredict (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women]
Time Frame: 5- and 10-years
Performance of EndoPredict in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women], assessed with distant recurrence free interval (DRFI).
5- and 10-years
OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
Time Frame: 5- and 10-years
OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
5- and 10-years
DRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
Time Frame: 5- and 10-years
DRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
5- and 10-years
DRFI in specific sub-groups (MFMC, node-positive, pre-menopausal women)
Time Frame: 5- and 10-years
DRFI in specific sub-groups (MFMC, node-positive, pre-menopausal women)
5- and 10-years
LRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
Time Frame: 5- and 10-years
LRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
5- and 10-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84/18.03.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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