Breast Cancer Early Stage Breast Cancer (Stage 1-3)PORTENTNCT07372261

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

An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
What is being tested?: Validation of Prognostic tool
How many people: 1,000 participants
Where: 1 siteItaly
Study dates: 10 Mar 2022to 31 Dec 2026
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
Women only
No healthy volunteers
Adult, Older adult

Study population: The study includes three cohorts: CSS-cohort_2: 350 cases with ≥5 years follow-up, prospectively enrolled 2014-2019 within the TRANSCAN-BREMIR Study (Refs: Prot 116/CE 30/09/2014; Prot 140/CE 28/10/2014; Prot 150/CE 24/10/2018). External cohort: ≥450 patients with available residual tumor tissue, retrospectively selected; each center enrolls ≥75 patients (60 disease-free ≥5 years, 15 with metastatic progression ≥3 years). INT_Milan cohort: 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with pre-treatment and/or surgical residual tumor tissue available.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site

Fondazione Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, FG, 71013

Other trials in Italy

About this study

Official title: Dissecting the Role of miR-3916 and miR3613-5p in Breast Cancer and Developing a Metastases Predictor PORTENT Algorithm

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

Read the detailed 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.

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Being tested: Validation of Prognostic tool
Keywords: microRNA, metastases, prognosis
Medical subject headings: Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Validation of Prognostic toolDiagnostic test
Collection of Clinical History: Clinical data, including medical history, clinicopathological features (e.g., age, histology, receptor and nodal status), and follow-up information (presence or absence of metastasis, patient vital status), will be collected and entered into a dedicated platform by. Follow-up updates are scheduled by Month 48 of the project (December 31, 2025) to ensure timely and accurate patient outcome data.
Laboratory Analysis: Residual tumor sections prepared by the Pathology Unit of each participating center will be sent to the Oncology Laboratory at CSS-IRCCS, where RNA will be extracted using standardized experimental procedures. Expression levels of miR-3916, miR-3613-5p, and their target genes will be analyzed by quantitative real-time PCR (RT-qPCR). Protein expression of target genes will be assessed via immunohistochemistry. Additionally, the extracted RNA will be analyzed at the Gerobiomics and Exposomics Laboratory of IRST IRCCS.

Study groups in NCT07372261
Study group	Role	What they receive
CSS Cohort		350 stage 1 to 3A patients will be selected from the BREMIR study (ID NCT06555354) prospective cohort. Receives: Diagnostic Test: Validation of Prognostic tool
External Cohort		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. Receives: Diagnostic Test: Validation of Prognostic tool
INT-Milan		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. Receives: Diagnostic Test: Validation of Prognostic tool

What is being measured

The primary outcome is the main question the study is designed to answer.

Discriminatory Performance of the Prognostic Algorithm (AUC) for Prediction of Distant Metastasis Within 5 Years From Diagnosis
Area under the Receiver Operating Characteristic (ROC) curve (AUC) with 95% confidence intervals for patient-level risk probabilities generated by the prognostic algorithm to predict the occurrence of distant metastases within 5 years after breast cancer diagnosis. Discrimination will be assessed using ROC curve analysis and DeLong's test.
Measured: 5 years from diagnosis; interim analysis at March 2027.
Discriminatory Performance of the Prognostic Algorithm (AUC) for Prediction of Distant Metastasis Within 10 Years From Diagnosis
Area under the Receiver Operating Characteristic (ROC) curve (AUC) with 95% confidence intervals for patient-level risk probabilities generated by the prognostic algorithm to predict the occurrence of distant metastases within 10 years after breast cancer diagnosis. Discrimination will be assessed using ROC curve analysis and DeLong's test.
Measured: 10 years from diagnosis; final analysis after completion of 10-year follow-up for all participants (expected by 2029).

Secondary outcomes (8)

Calibration of the Prognostic Model at 5 Years (Integrated Calibration Index)
Calibration of the prognostic algorithm will be evaluated at 5 years using the Integrated Calibration Index (ICI) and calibration plots to assess agreement between predicted and observed distant metastasis risk.
Measured: 5 years from diagnosis; interim analysis at March 2027.
Calibration of the Prognostic Model at 10 Years (Integrated Calibration Index)
Calibration of the prognostic algorithm will be evaluated at 10 years using the Integrated Calibration Index (ICI) and calibration plots to assess agreement between predicted and observed distant metastasis risk.
Measured: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Difference in Discriminatory Performance Between Prognostic Models (ΔAUC) at 5 Years
Difference in AUC between the standard clinical prognostic model (clinicopathological variables only) and the extended model including miR-3916 and miR-3613-5p expression for prediction of distant metastases at 5 years. Statistical comparison will be performed using DeLong's test.
Measured: 5 years from diagnosis; interim analysis at March 2027.
Difference in Discriminatory Performance Between Prognostic Models (ΔAUC) at 10 Years
Difference in AUC between the standard clinical prognostic model (clinicopathological variables only) and the extended model including miR-3916 and miR-3613-5p expression for prediction of distant metastases at 10 years. Statistical comparison will be performed using DeLong's test.
Measured: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Classification Performance of the Prognostic Algorithm at 10 Years (Sensitivity, Specificity, PPV, NPV)
Estimation of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), with 95% confidence intervals, for predefined probability thresholds corresponding to low (<10%), intermediate (10-30%), and high (>30%) 10-year distant metastasis risk categories.
Measured: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Association Between miR-3916 and miR-3613-5p Expression and Overall Survival
Association between miR-3916 and miR-3613-5p expression levels and overall survival, assessed using hazard ratios and 95% confidence intervals from Cox proportional hazards models.
Measured: Up to 10 years from diagnosis; final analysis after completion of follow-up (expected by 2029).
Prognostic Algorithm Performance Within PAM50 Molecular Subgroups
Discriminatory performance and calibration of the prognostic algorithm within PAM50 molecular subgroups (Luminal A, Luminal B, HER2-enriched, Basal-like), evaluated using AUC and calibration metrics.
Measured: 5 and 10 years from diagnosis; final analysis after completion of follow-up (expected by 2029).
Analytical Validity of miRNA Expression Assessment
Assessment of analytical validity of miR-3916 and miR-3613-5p expression measurement, including RNA yield, RT-qPCR amplification success rate, and assay reproducibility. This outcome assesses technical performance only.
Measured: Data collection and analysis completed by March 2027.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202231 Dec 2026

First posted28 Jan 2026
Study start10 Mar 2022
Primary completionJun 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
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: Other
Time perspective: Retrospective
Enrolment: 1,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07372261
Sponsor's protocol ID: PORTENT
Acronym: PORTENT
Status last verified: Jan 2026
First submitted: 4 Aug 2025
Last updated: 30 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (IPD), including raw tumor expression data, clinicopathological features, and follow-up information collected during this study, may be shared with participating centers and other qualified researchers upon formal request. Data sharing will be conducted under strict data use agreements to ensure confidentiality, data security, and compliance with all applicable ethical and legal standards. Access to IPD will be granted solely for scientifically valid, collaborative research purposes following approval by the study steering committee or data access committee. Requests must include a detailed research proposal, data management plan, and evidence of ethical approval. This policy promotes transparency, facilitates scientific collaboration, and aims to maximize the utility of collected data while protecting participant privacy and rights.

Publications

Fontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4.
PubMed 41024243

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dissecting the Role of miR-3916 and miR3613-5p in Breast Cancer and Developing a Metastases Predictor PORTENT Algorithm
ClinicalTrials.gov ID: NCT07372261
Acronym / sponsor ID: PORTENT / PORTENT
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: microRNA, metastases, prognosis
Study type: Observational
Recruitment status: Enrolling by invitation
Enrolment: 1,000 participants (estimated)
Lead sponsor: Casa Sollievo della Sofferenza IRCCSUniversity, hospital or other
Collaborators: Istituti Tumori Giovanni Paolo II, IRCCS Centro di Riferimento Oncologico della Basilicata, Fondazione Humanitas per la Ricerca, Fondazione IRCCS Policlinico San Matteo di Pavia, Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, Istituto Nazionale Tumori Regina Elena, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Study start: 10 Mar 2022 (actual)
Primary completion: Jun 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 28 Jan 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 primary objective is to assess the discriminatory ability of the PORTENT algorithm for predicting distant metastasis at predefined time points after diagnosis.

Detailed description

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
CSS Cohort	–	Diagnostic Test: Validation of Prognostic tool350 stage 1 to 3A patients will be selected from the BREMIR study (ID NCT06555354) prospective cohort.
External Cohort	–	Diagnostic Test: Validation of Prognostic toolThe 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.
INT-Milan	–	Diagnostic Test: Validation of Prognostic toolThe INT_Milan cohort includes 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with available pre-treatment and/or surgical residual tumor tissue.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study includes three cohorts: CSS-cohort_2: 350 cases with ≥5 years follow-up, prospectively enrolled 2014-2019 within the TRANSCAN-BREMIR Study (Refs: Prot 116/CE 30/09/2014; Prot 140/CE 28/10/2014; Prot 150/CE 24/10/2018). External cohort: ≥450 patients with available residual tumor tissue, retrospectively selected; each center enrolls ≥75 patients (60 disease-free ≥5 years, 15 with metastatic progression ≥3 years). INT_Milan cohort: 300 Luminal A breast cancer cases treated with neoadjuvant therapy, with pre-treatment and/or surgical residual tumor tissue available.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Validation of Prognostic toolCollection of Clinical History: Clinical data, including medical history, clinicopathological features (e.g., age, histology, receptor and nodal status), and follow-up information (presence or absence of metastasis, patient vital status), will be collected and entered into a dedicated platform by. Follow-up updates are scheduled by Month 48 of the project (December 31, 2025) to ensure timely and accurate patient outcome data. Laboratory Analysis: Residual tumor sections prepared by the Pathology Unit of each participating center will be sent to the Oncology Laboratory at CSS-IRCCS, where RNA will be extracted using standardized experimental procedures. Expression levels of miR-3916, miR-3613-5p, and their target genes will be analyzed by quantitative real-time PCR (RT-qPCR). Protein expression of target genes will be assessed via immunohistochemistry. Additionally, the extracted RNA will be analyzed at the Gerobiomics and Exposomics Laboratory of IRST IRCCS.	Diagnostic test	CSS Cohort, External Cohort, INT-Milan

Primary outcome

Discriminatory Performance of the Prognostic Algorithm (AUC) for Prediction of Distant Metastasis Within 5 Years From Diagnosis
Time frame: 5 years from diagnosis; interim analysis at March 2027.
Area under the Receiver Operating Characteristic (ROC) curve (AUC) with 95% confidence intervals for patient-level risk probabilities generated by the prognostic algorithm to predict the occurrence of distant metastases within 5 years after breast cancer diagnosis. Discrimination will be assessed using ROC curve analysis and DeLong's test.
Discriminatory Performance of the Prognostic Algorithm (AUC) for Prediction of Distant Metastasis Within 10 Years From Diagnosis
Time frame: 10 years from diagnosis; final analysis after completion of 10-year follow-up for all participants (expected by 2029).
Area under the Receiver Operating Characteristic (ROC) curve (AUC) with 95% confidence intervals for patient-level risk probabilities generated by the prognostic algorithm to predict the occurrence of distant metastases within 10 years after breast cancer diagnosis. Discrimination will be assessed using ROC curve analysis and DeLong's test.

8 secondary outcomes

Calibration of the Prognostic Model at 5 Years (Integrated Calibration Index)
Time frame: 5 years from diagnosis; interim analysis at March 2027.
Calibration of the Prognostic Model at 10 Years (Integrated Calibration Index)
Time frame: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Difference in Discriminatory Performance Between Prognostic Models (ΔAUC) at 5 Years
Time frame: 5 years from diagnosis; interim analysis at March 2027.
Difference in Discriminatory Performance Between Prognostic Models (ΔAUC) at 10 Years
Time frame: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Classification Performance of the Prognostic Algorithm at 10 Years (Sensitivity, Specificity, PPV, NPV)
Time frame: 10 years from diagnosis; final analysis after completion of 10-year follow-up (expected by 2029).
Association Between miR-3916 and miR-3613-5p Expression and Overall Survival
Time frame: Up to 10 years from diagnosis; final analysis after completion of follow-up (expected by 2029).
Prognostic Algorithm Performance Within PAM50 Molecular Subgroups
Time frame: 5 and 10 years from diagnosis; final analysis after completion of follow-up (expected by 2029).
Analytical Validity of miRNA Expression Assessment
Time frame: Data collection and analysis completed by March 2027.

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 30 Jan 2026.
Background: PubMed 41024243Fontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4.
Individual participant dataSharing planned: Yes. Individual participant data (IPD), including raw tumor expression data, clinicopathological features, and follow-up information collected during this study, may be shared with participating centers and other qualified researchers upon formal request. Data sharing will be conducted under strict data use agreements to ensure confidentiality, data security, and compliance with all applicable ethical and legal standards. Access to IPD will be granted solely for scientifically valid, collaborative research purposes following approval by the study steering committee or data access committee. Requests must include a detailed research proposal, data management plan, and evidence of ethical approval. This policy promotes transparency, facilitates scientific collaboration, and aims to maximize the utility of collected data while protecting participant privacy and rights.

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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.

Paola Parrella, MD principal investigator

Fondazione Casa Sollievo della Sofferenza, IRCCS

1 site 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 Early Stage Breast Cancer (Stage 1-3), run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.

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 3 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: enrolling by invitation, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Discriminatory Performance of the Prognostic Algorithm (AUC) for Prediction of Distant Metastasis Within 5 Years From Diagnosis (time frame: 5 years from diagnosis; interim analysis at March 2027.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07372261, which also lists 1 linked publication.

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 30 Jan 2026.