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
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
2,000
"Elena Venizelou" General Hospital, Department of Surgery
Athens, Greece
RECRUITING"Prolipsis" Center, Breast Unit
Athens, Greece
RECRUITINGHenry Dunant Hospital Center, 3rd Breast Surgical Department
Athens, Greece
RECRUITINGLaiko Hospital, National and Kapodistrian University of Athens, Medical School
Athens, Greece
RECRUITINGMediterraneo Hospital, Breast Clinic
Athens, Greece
RECRUITINGMetropolitan General Hospital, 3rd Breast Clinic
Cholargós, Greece
RECRUITINGMetropolitan General Hospital, 4th Breast Clinic
Cholargós, Greece
RECRUITING"Apollonio-Theotokos" General Clinic, Department of Surgery
Larissa, Greece
RECRUITINGIASO Thessalias General Clinic, Breast Surgery Department
Larissa, Greece
RECRUITINGIASO General Clinic, 2nd Breast Clinic
Marousi, Greece
RECRUITING...and 3 more locations
Distant relapse free survival (DRFS)
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.
Time frame: 5- and 10-years
Overall Survival (OS)
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.
Time frame: 5- and 10-years
Distant relapse free interval (DRFI)
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.
Time frame: 5- and 10-years
Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score
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.
Time frame: Up to 2 months post-operatively
Local relapse free survival (LRFS)
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.
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]
Performance of EndoPredict in specific population subgroups \[multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women\], assessed with distant recurrence free survival (DRFS).
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]
Performance of EndoPredict in specific population subgroups \[multifocal-multicentric disease (MFMC), node-positive patients, pre-menopausal women\], assessed with distant recurrence free interval (DRFI).
Time frame: 5- and 10-years
OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
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)
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)
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)
LRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)
Time frame: 5- and 10-years
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