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Understanding neoadjuvant treatment in early-stage breast cancer

EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase: Retrospective Multicentre Study on the Therapeutic Approach Most Commonly Adopted in the Italian Oncology Centres

Observational Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06894173

This study looks at how many patients with early-stage HER2-positive and Triple Negative breast cancer received treatment before surgery over the last five years, and what types of treatments and surgeries they had.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other
Locations29 sites (Aviano, PN and 28 other locations)
Trial IDNCT06894173 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with early-stage HER2-positive or Triple Negative breast cancer who have undergone neoadjuvant treatment.

Not a fit: Patients with documented distant disease at diagnosis or those who have received prior neoadjuvant hormonal treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment strategies for patients with specific breast cancer subtypes, leading to improved outcomes.

How similar studies have performed: Other studies focusing on neoadjuvant treatment in breast cancer have shown promising results, indicating that this approach is both relevant and potentially beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Aviano, PN and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.