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
Trial Information
Current as of April 30, 2025
Recruiting
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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, , Italy
Roma, , Italy
Potenza, , Italy
Parma, , Italy
Roma, , Italy
Roma, , Italy
Prato, , Italy
Novara, , Italy
Catania, , Italy
Aviano, Pn, Italy
Ancona, , Italy
Avellino, , Italy
Brindisi, , Italy
Genova, , Italy
Mantova, , Italy
Meldola, , Italy
Milano, , Italy
Modena, , Italy
Napoli, , Italy
Napoli, , Italy
Napoli, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Sondalo, , Italy
Torino, , Italy
Trento, , Italy
Viterbo, , Italy
Patients applied
Trial Officials
Alessandra Fabi
Principal Investigator
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
Antonella Palazzo
Principal Investigator
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Oncologia Medica
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported