Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · May 28, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the factors that might increase the risk of breast cancer coming back in women who have locally advanced breast cancer and have received chemotherapy before surgery, a treatment known as neoadjuvant chemotherapy. Researchers want to understand why some patients experience early disease recurrence (EDR), which means the cancer returns within three years after treatment. They are particularly interested in using advanced imaging techniques, like MRI, to help predict which patients may be more likely to face this challenge.
To participate in this trial, women over 18 years old with specific types of locally advanced breast cancer (including triple-negative and HER2-positive) that have undergone neoadjuvant chemotherapy between January 2014 and June 2021 may be eligible. Participants will have their clinical data and MRI images analyzed to help improve understanding of cancer recurrence. This research aims to provide better predictions for future patients and ultimately improve treatment outcomes for women facing breast cancer.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Histological diagnosis of locally advanced Luminal or HER2+ or Triple-negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage of disease from I to III.
- • Patient undergoing neoadjuvant chemotherapy treatment from January 1, 2014, to June 30, 2021.
- • Age \> 18 years
- • Availability of clinical data, staging MRI diagnostic images (for the radiomic sub-study), and biomolecular data.
- Exclusion Criteria:
- • Previous or synchronous history of systemic malignancies.
- • History of ipsilateral or contralateral breast neoplasia.
- • Evidence of metastatic disease (Stage IV).
- • Neoadjuvant treatment with hormone therapy.
- • Patients with unavailable or low-quality MRI images that did not allow lesion identification (for the radiomic study only).
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
Roma, , Italy
Patients applied
Trial Officials
Alessandra Fabi
Principal Investigator
Policlinico Gemelli
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported