A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing

NCT07389408 | Recruiting

• 1 other identifier: 84/18.03.2025
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 13

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

Conditions

Breast Cancer; Breast Adenocarcinoma

Keywords

breast cancer; luminal subtype; EndoPredict; genetic signature; survival

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 2 months post-operatively

Secondary Outcomes (7)

• Local relapse free survival (LRFS)

  5- and 10-years

• 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 (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women]

  5- and 10-years

• OS 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)

  5- and 10-years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Age ≥ 18 years old.
• Histological diagnosis of invasive breast cancer.
• T1-T3 tumor size.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (13)

"Elena Venizelou" General Hospital, Department of Surgery

Athens, Greece

RECRUITING

"Prolipsis" Center, Breast Unit

Athens, Greece

RECRUITING

Henry Dunant Hospital Center, 3rd Breast Surgical Department

Athens, Greece

RECRUITING

Laiko Hospital, National and Kapodistrian University of Athens, Medical School

Athens, Greece

RECRUITING

Mediterraneo Hospital, Breast Clinic

Athens, Greece

RECRUITING

Metropolitan General Hospital, 3rd Breast Clinic

Cholargós, Greece

RECRUITING

Metropolitan General Hospital, 4th Breast Clinic

Cholargós, Greece

RECRUITING

"Apollonio-Theotokos" General Clinic, Department of Surgery

Larissa, Greece

RECRUITING

IASO Thessalias General Clinic, Breast Surgery Department

Larissa, Greece

RECRUITING

IASO General Clinic, 2nd Breast Clinic

Marousi, Greece

RECRUITING

MITERA, 1st Breast Clinic

Marousi, Greece

RECRUITING

Thessaloniki Bioclinic Hospital, Breast Unit

Thessaloniki, Greece

RECRUITING

General Hospital of Trikala, Breast Surfery Dept.

Trikala, Greece

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Michalis Kontos

CONTACT

+30 2132060800; michalis_kontos@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Breast and General Surgery

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 5, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

GR (13)