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NCT Number: NCT06807749

Adjuvant Treatment in Premenopausal Breast Cancer

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.

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Key information

Conditions

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

Age range

Up to 60 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Evidence of distant metastases
  • Inflammatory breast cancer
  • Neoadjuvant treatment
  • No surgery for primary breast cancer and axillary staging
  • Patients not tested with 21-multigene assay Oncotype DX

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Technology

CONTACT

[email protected]

0039 089 301545

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Collaborators

  • Clinical Research Technology S.r.l.

Registry information

Official study title

PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test

Acronym: PERSEVEREX

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 4, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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