Adjuvant Treatment in Premenopausal Breast Cancer

PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06807749

Acronym

PERSEVEREX

Enrollment

800

Registered

2025-02-04

Start date

2025-12-24

Completion date

2027-09-01

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Premenopausal early breast cancer, Oncotype Dx

Brief summary

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Invasive Disease-Free Survival (iDFS) at 5 years	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

Measure	Time frame	Description
To describe the effect of the different adjuvant treatments according to clinical and genomic risk	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.

Countries

Italy

Contacts

CONTACTClinical Research Technology

perseverex@cr-technology.com0039 089 301545

PRINCIPAL_INVESTIGATORAntonella Palazzo

Fondazione Policlinico Gemelli, IRCCS

STUDY_CHAIRAlessandra Fabi