Adjuvant Treatment in Premenopausal Breast Cancer

Not yet recruiting

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

• Registration Number: NCT06807749
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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).

Study Timeline

• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Study Start: 2025-04
• Primary Completion: 2026-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Clinical Research Technology; 🇮🇹 Salerno, Italy