Validation of a Prognostic Method for Assessing the Risk of Distant Metastasis in Early-stage Breast Cancer (PORTENT)

Casa Sollievo della Sofferenza IRCCS

Status: Invitation-only

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Treatments: Diagnostic Test: Validation of Prognostic tool

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT07372261

PORTENT

Details and patient eligibility

About

This is a multicenter, observational validation study designed to evaluate the prognostic performance of the PORTENT algorithm in patients with early-stage breast cancer. The model integrates clinicopathological variables and the expression levels of two small non-coding RNAs (miR-3916 and miR-3613-5p) to estimate individual risk of developing distant metastases.

The primary objective is to assess the discriminatory ability of the PORTENT algorithm for predicting distant metastasis at predefined time points after diagnosis.

Full description

This multicenter retrospective observational study aims to clinically validate the PORTENT prognostic algorithm for predicting the risk of distant metastases in women with early-stage breast cancer. Female patients with Stage I-III disease from three independent cohorts with available residual tumor tissue and follow-up data will be included.

The primary endpoint of the study is the discriminatory performance of the PORTENT algorithm, assessed by the area under the receiver operating characteristic curve (AUC) for the prediction of distant metastases at 5 and 10 years from diagnosis.

The algorithm integrates established clinicopathological prognostic factors (tumor stage, histological grade, and Ki67-MIB1) with the expression levels of miR-3916 and miR-3613-5p. MicroRNA expression and target protein expression will be evaluated using RT-qPCR and immunohistochemistry.

Secondary and exploratory analyses will include model calibration assessed using calibration curves and the Integrated Calibration Index (ICI), as well as survival analyses (overall survival, progression-free survival, and metastasis-free survival) performed using Cox proportional hazards models.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Stage I-III breast cancer
• Residual tumor tissue available
• Written informed consent

Exclusion criteria

• Age <18
• Stage IV at diagnosis
• Refusal or inability to provide informed consent

Trial design

1,000 participants in 3 patient groups

CSS Cohort

Description:

350 stage 1 to 3A patients will be selected from the BREMIR study (ID NCT06555354) prospective cohort.

Treatment:

Diagnostic Test: Validation of Prognostic tool

External Cohort

Description:

The External\_cohort will include patients enrolled retrospectively from the centers participating in the study. A total of at least 450 patients will be selected, with residual tumor tissue available at the respective Pathology Departments. Each center will enroll a minimum of 75 patients, comprising 60 who remain disease-free after at least 5 years of follow-up and 15 who experience metastatic progression after at least 3 years of follow-up.

Treatment:

Diagnostic Test: Validation of Prognostic tool

INT-Milan

Description:

The INT\_Milan cohort includes 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with available pre-treatment and/or surgical residual tumor tissue.

Treatment:

Diagnostic Test: Validation of Prognostic tool