Treatment choices and outcomes for early luminal breast cancer patients eligible for EndoPredict testing

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

This project will see how EndoPredict testing relates to treatment choices and long-term outcomes for adults with early ER-positive/HER2-negative breast cancer.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Athens and 12 other locations)
• Trial ID: NCT07389408 on ClinicalTrials.gov

What this trial studies

PRELUDE is a prospective, multicenter, non-interventional registry enrolling up to 2,000 adults with ER-positive/HER2-negative (luminal) early breast cancer who are eligible for EndoPredict testing. Participants may or may not undergo the EndoPredict test, and will be followed once per year for up to 10 years after surgery to document treatments and clinical outcomes. The registry will compare 5- and 10-year outcomes by EndoPredict (EP/EPclin) risk groups and analyze how patient and tumor characteristics influence adjuvant treatment decisions in routine clinical practice. The study is planned at about 10–20 sites primarily in Greece, with the option to add sites elsewhere if needed.

Who should consider this trial

Good fit: Adults (≥18) with histologically confirmed invasive ER-positive/HER2-negative breast cancer (T1–T3, 0–3 positive axillary nodes) who are eligible for EndoPredict testing and can enroll after surgery but before starting adjuvant endocrine therapy are ideal candidates.

Not a fit: Patients with HER2-positive or triple-negative disease, those who received pre-operative chemotherapy, or those with another recent primary cancer are not eligible and are unlikely to benefit from this registry's findings.

Why it matters

Potential benefit: If successful, the registry could help doctors personalize adjuvant therapy decisions and reduce unnecessary chemotherapy for some patients.

How similar studies have performed: Genomic signatures including EndoPredict and other tests have shown prognostic value in prior validation studies, but large prospective real-world registries like this are less common.

Eligibility criteria

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 this trial is running

Athens and 12 other locations

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

Study contacts

• Study coordinator: Michalis Kontos

Conditions Breast Cancer; Breast Adenocarcinoma; breast cancer; luminal subtype; EndoPredict; genetic signature; survival