Adjuvant Treatment in Premenopausal Breast Cancer (PERSEVEREX)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06807749

7296

Details and patient eligibility

About

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.

Full 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).

Enrollment: 800 estimated patients

Sex: Female

Ages: Under 60 years old

Volunteers: No 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

Trial design

800 participants in 2 patient groups

node negative (pN0)

Description:

Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test

node positive (pN1)

Description:

Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test