Breast CancerPRELUDENCT07389408
A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
An observational study of Breast Cancer and Breast Adenocarcinoma, run by National and Kapodistrian University of Athens at 13 sites in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Adenocarcinoma
- How many people
- 2,000 participants
- Where
- 13 sitesGreece
- Study dates
- 1 Apr 2025to 31 Dec 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All subjects diagnosed with invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Greece13 sites, 13 recruiting
- Recruiting
"Elena Venizelou" General Hospital, Department of Surgery
Athens
Georgios Metaxas, +30 2132051000, geometa@hotmail.com
- Recruiting
"Prolipsis" Center, Breast Unit
Athens
Petros Charalampoudis, +30 2107483110, petros.charalampoudis@gmail.com
- Recruiting
Henry Dunant Hospital Center, 3rd Breast Surgical Department
Athens
Ioannis Flessas, +30 2106972187, iflessas@gmail.com
- Recruiting
Laiko Hospital, National and Kapodistrian University of Athens, Medical School
Athens
Michalis Kontos, +30 2132060800, michalis_kontos@yahoo.com
- Recruiting
Mediterraneo Hospital, Breast Clinic
Athens
Vasileios Kalles, +30 2109117000, vassilis_kalles@yahoo.gr
- Recruiting
Metropolitan General Hospital, 3rd Breast Clinic
Cholargós
Dimitrios Koronarchis, +30 2106502607, dikoron@yahoo.gr
- Recruiting
Metropolitan General Hospital, 4th Breast Clinic
Cholargós
Stergios Douvetzemis, +30 2106502885, stergiosdouvetzemis@yahoo.gr
- Recruiting
"Apollonio-Theotokos" General Clinic, Department of Surgery
Larissa
Apostolos Zavos, +30 2410282006, zavosa@gmail.com
- Recruiting
IASO Thessalias General Clinic, Breast Surgery Department
Larissa
Georgios Boutsikos, +30 2410996000, george.boutsikos@gmail.com
- Recruiting
IASO General Clinic, 2nd Breast Clinic
Marousi
Grigorios Xepapadakis, +30 2106383721, gxepapadakis@gmail.com
- Recruiting
MITERA, 1st Breast Clinic
Marousi
Christina Tsionou, +30 2106869934, chtsionou@mitera.gr
- Recruiting
Thessaloniki Bioclinic Hospital, Breast Unit
Thessaloniki
Stavros Chatzopoulos, +30 2310372600, stavroschatzopoulos@yahoo.com
- Recruiting
General Hospital of Trikala, Breast Surfery Dept.
Trikala
Maria Kanara, +30 2431350466, makanara1@hotmail.com
About this study
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
Read the 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.
- Conditions
- Breast Cancer, Breast Adenocarcinoma
- Keywords
- breast cancer, luminal subtype, EndoPredict, genetic signature, survival
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-metastatic breast cancer N0-N1 patients eligible for EndoPredict testing | Subjects diagnosed with non-metastatic invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing. No intervention is planned, as this is an observational study and treatment of patients will not be changed due to their participation in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 months post-operatively
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 5- and 10-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Apr 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michalis Kontos, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389408
- Sponsor's protocol ID
- 84/18.03.2025
- Acronym
- PRELUDE
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
- ClinicalTrials.gov ID
- NCT07389408
- Acronym / sponsor ID
- PRELUDE / 84/18.03.2025
- Conditions
- Breast Cancer, Breast Adenocarcinoma
- Keywords
- breast cancer, luminal subtype, EndoPredict, genetic signature, survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-metastatic breast cancer N0-N1 patients eligible for EndoPredict testing | – | –Subjects diagnosed with non-metastatic invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing. No intervention is planned, as this is an observational study and treatment of patients will not be changed due to their participation in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects diagnosed with invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Adenocarcinoma, run by National and Kapodistrian University of Athens at 13 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michalis Kontos (+30 2132060800, michalis_kontos@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant relapse free survival (DRFS) (time frame: 5- and 10-years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.