Breast Adenocarcinoma, Breast Cancer
Conditions
Keywords
breast cancer, luminal subtype, EndoPredict, genetic signature, survival
Brief summary
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.
Interventions
None listed
Sponsors
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distant relapse free survival (DRFS) | 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. |
| Overall Survival (OS) | 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. |
| Distant relapse free interval (DRFI) | 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. |
| Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score | 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
| Measure | Time frame | Description |
|---|---|---|
| Local relapse free survival (LRFS) | 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. |
| Performance of EndoPredict (assessed with DRFS) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women] | 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). |
| Performance of EndoPredict (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women] | 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). |
| OS in specific sub-groups (MFMC, node-positive, pre-menopausal women) | 5- and 10-years | OS in specific sub-groups (MFMC, node-positive, pre-menopausal women) |
| DRFS 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) |
| DRFI 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) |
| LRFS 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) |
Countries
Greece
Contacts
CONTACTMichalis Kontos
Outcome results
None listed