A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Distant relapse free survival (DRFS) [Time frame: 5- and 10-years]
- Overall Survival (OS) [Time frame: 5- and 10-years]
- Distant relapse free interval (DRFI) [Time frame: 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]
Secondary outcome measures (7)
- Local relapse free survival (LRFS) [Time frame: 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 (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women] [Time frame: 5- and 10-years]
- OS 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) [Time frame: 5- and 10-years]
- DRFI 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) [Time frame: 5- and 10-years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 13 centers
- "Elena Venizelou" General Hospital, Department of Surgery — Athens
- "Prolipsis" Center, Breast Unit — Athens
- Henry Dunant Hospital Center, 3rd Breast Surgical Department — Athens
- Laiko Hospital, National and Kapodistrian University of Athens, Medical School — Athens
- Mediterraneo Hospital, Breast Clinic — Athens
- Metropolitan General Hospital, 3rd Breast Clinic — Cholargós
- Metropolitan General Hospital, 4th Breast Clinic — Cholargós
- "Apollonio-Theotokos" General Clinic, Department of Surgery — Larissa
- … and 5 more centers
Identifiers
NCT: NCT07389408 · 84/18.03.2025