Adjuvant Treatment in Premenopausal Breast Cancer

NCT06807749 | Not Yet Recruiting DMC

• 1 other identifier: 7296
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Premenopausal early breast cancer; Oncotype Dx

Outcome Measures

Primary Outcomes (1)

• Invasive Disease-Free Survival (iDFS) at 5 years

  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.

  up to 30 months

Secondary Outcomes (1)

• To describe the effect of the different adjuvant treatments according to clinical and genomic risk

  up to 30 months

Study Arms (2)

node negative (pN0)

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

node positive (pN1)

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

Eligibility Criteria

• Age: Up to 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• Clinical Research Technology S.r.l.: collaborator

Study Sites (1)

Clinical Research Technology

Salerno, Italy

Location

Study Officials

• Antonella Palazzo

  Fondazione Policlinico Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

• Alessandra Fabi

  Fondazione Policlinico Gemelli, IRCCS

  STUDY CHAIR

Central Study Contacts

Clinical Research Technology

CONTACT

0039 089 301545; perseverex@cr-technology.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 4, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)