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NCT Number: NCT07389408

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

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Key information

Conditions

Breast Cancer Breast Adenocarcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

"Elena Venizelou" General Hospital, Department of Surgery, Athens, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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. 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)

  6. 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)

  7. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Michalis Kontos

CONTACT

[email protected]

+30 2132060800

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Acronym: PRELUDE

Important dates

Study start
2025
Primary completion
2028
Study completion
2038
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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