EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial, called the EvoLution of Neoadjuvant TreatMent, focuses on understanding how many patients with specific types of breast cancer—HER2-positive and Triple Negative—have received neoadjuvant treatment (a therapy given before surgery) in the last five years. The study will look at various factors, such as the types of treatment chosen, the characteristics of the tumors, and how well the treatments worked. Researchers will also analyze how these treatments may affect patients' chances of staying cancer-free after surgery.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of early-stage breast cancer without any spread to other parts of the body. They should also have specific information about their cancer, such as hormone receptor status. Participants can expect to share their treatment experiences and undergo assessments that will help researchers gather important information about the effectiveness of neoadjuvant treatments. This trial is actively recruiting patients and aims to improve future breast cancer care.

Gender

ALL

Eligibility 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