Clinical trial NCT06807749: Adjuvant Treatment in Premenopausal Breast Cancer
Official title: PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: Premenopausal early breast cancer
Oncotype Dx
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
Collaborators: name: Clinical Research Technology S.r.l.
First posted: 2025-02-04
Enrollment: 800
Sex: FEMALE
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Invasive Disease-Free Survival (iDFS) at 5 years
timeFrame: up to 30 months
Secondary outcomes:
measure: To describe the effect of the different adjuvant treatments according to clinical and genomic risk
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Salerno
country: Italy
facility: Clinical Research Technology
Study officials:
affiliation: Fondazione Policlinico Gemelli, IRCCS
name: Antonella Palazzo
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Policlinico Gemelli, IRCCS
name: Alessandra Fabi
role: STUDY_CHAIR
References: