Adjuvant Treatment in Premenopausal Breast Cancer (PERSEVEREX)

March 21, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test

Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Premenopausal patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 with any Recurrence Score (RS) and pathological nodal status pN0/pN1 will be included in the study. The study will collect clinical-pathological, genomic characteristics, adjuvant treatments (chemotherapy, endocrine therapy with/without OFS), and survival outcome (iDFS).

Study Type

Observational

Enrollment (Estimated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with premenopausal early breast cancer HR+ HER2 negative diagnosis with any Recurrence Score (RS) and pathological nodal status pN0/pN1 and who underwent the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.

Description

Inclusion Criteria:

  1. Female, premenopausal and ≥18 years age patients.
  2. Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
  3. Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
  4. Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT3.
  5. Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
  6. Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022
  7. Availability of clinical and pathological information.
  8. Availability of information about adjuvant treatment received.
  9. Availability of patient' outcome information (relapse, site of relapse, survival).

Exclusion Criteria:

  1. Evidence of distant metastases
  2. Inflammatory breast cancer
  3. Neoadjuvant treatment
  4. No surgery for primary breast cancer and axillary staging
  5. Patients not tested with 21-multigene assay Oncotype DX

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
node negative (pN0)
Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test
node positive (pN1)
Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-Free Survival (iDFS) at 5 years
Time Frame: up to 30 months
The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To describe the effect of the different adjuvant treatments according to clinical and genomic risk
Time Frame: up to 30 months
Descriptive statistics, statistical measure of association, and logistic binomial regression modeling of the association measures between the iDFS at 5 years and explicative variables including adjuvant treatment received (chemo/endocrine therapy; endocrine therapy with or without OSF), pathological tumor status, and genomic risk score according to 21-multigene assay Oncotype DX.
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborators

Clinical Research Technology S.r.l.

Investigators

  • Principal Investigator: Antonella Palazzo, Fondazione Policlinico Gemelli, IRCCS
  • Study Chair: Alessandra Fabi, Fondazione Policlinico Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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