Understanding neoadjuvant treatment in early-stage breast cancer

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 observational study aims to analyze the percentage of patients with HER2-positive and Triple Negative breast cancer who received neoadjuvant treatment over the past five years. It will assess treatment choices based on molecular subtype and initial staging, as well as evaluate clinical and tumor characteristics. Additionally, the study will examine the radiological responses to neoadjuvant therapy and the types of surgical procedures performed. The data will be collected from multiple sites to provide a comprehensive overview of current practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For primary endpoint assessment we calculated the percentage of HER2 positive and Triple Negative patients who underwent neoadjuvant treatment in the past 5 years in each site. For this aim all patients with early breast cancer diagnosis who underwent neoadjuvant treatment during the study time, ranging from 01/01/2016 to 01/01/2021, will be included if they had:
* Histological diagnosis of infiltrating breast cancer performed by breast and/or axillary nodes biopsy;
* Age ≥ 18 years at the time of disease onset;
* Absence of secondary lesions, i.e. initial disease stage I, II or III;
* Known status of ER, PgR, HER-2 and Ki67.

Exclusion Criteria:

* Documented distant disease at onset diagnosis or within 3 months from breast surgery;
* Prior neoadjuvant hormonal treatment exposure;
* Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ

Where it's running

• A.O.R.N. "San Giuseppe Moscati"
  Avellino, Italy Recruiting
• ASST - Azienda Ospedaliera Carlo Poma di Mantova
  Mantua, Italy Recruiting
• Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
  Meldola, Italy Recruiting
• Istituto Nazionale Tumori di Napoli - IRCCS Istituto Pascale
  Naples, Italy Recruiting
• Nuovo Ospedale di Prato - S. Stefano
  Prato, Italy Recruiting
• Fondazione Policlinico A. Gemelli, IRCCS
  Roma, Italy Recruiting

Study contacts

• Principal investigator: Alessandra Fabi — Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
• Study coordinator: Alessandra Fabi, MD
• Email: alessandra.fabi@policlinicogemelli.it
• Phone: 0630157337

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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.