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Not yet recruiting NCT06807749

Adjuvant Treatment in Premenopausal Breast Cancer

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: up to 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test

Overview

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.

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).

Primary outcome measures

  • Invasive Disease-Free Survival (iDFS) at 5 years [Time frame: up to 30 months]
Secondary outcome measures (1)
  • To describe the effect of the different adjuvant treatments according to clinical and genomic risk [Time frame: up to 30 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Clinical Research Technology — Salerno

Identifiers

NCT: NCT06807749 · 7296

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗