Adjuvant Treatment in Premenopausal Breast Cancer (Oncotype DX-Based)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, retrospective observational study collects data on premenopausal women with early-stage breast cancer (stages 1–3) who underwent the Oncotype DX 21-gene assay between 2013 and 2022. It gathers clinical, pathological, and genomic information, along with adjuvant treatments such as chemotherapy or endocrine therapy (with or without ovarian function suppression), and tracks survival outcomes like invasive disease-free survival. The goal is to understand how Oncotype DX results and treatment choices relate to relapse and survival in this population. No specific intervention is being tested; the study analyzes real-world treatment patterns and outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione Policlinico Gemelli
  Roma, Antonella Palazzo, Italy Recruiting
• Clinical Research Technology
  Salerno, Italy Not yet recruiting

Study contacts

• Principal investigator: Antonella Palazzo — Fondazione Policlinico Gemelli, IRCCS
• Study coordinator: Clinical Research Technology
• Email: perseverex@cr-technology.com
• Phone: 0039 089 301545

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.