Evaluating recurrence risk factors in advanced breast cancer after chemotherapy
Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy. The NEORISK Study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06441240
This study is trying to find out what factors might increase the chance of breast cancer coming back in patients with locally advanced breast cancer after they have had chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 933 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Roma) |
| Trial ID | NCT06441240 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with locally advanced breast cancer who have undergone neoadjuvant chemotherapy. It aims to evaluate various risk factors associated with the recurrence of breast cancer, particularly in those with triple-negative and HER2-positive subtypes. The study will utilize clinical data, MRI diagnostic images, and biomolecular data collected from patients treated between January 2014 and June 2021. By analyzing these factors, the study seeks to improve understanding of treatment outcomes and recurrence risks.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with locally advanced breast cancer who have received neoadjuvant chemotherapy.
Not a fit: Patients with a history of systemic malignancies or metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify patients at higher risk of recurrence, leading to more personalized treatment plans.
How similar studies have performed: Other studies have shown promise in evaluating recurrence risks in breast cancer, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli - IRCCS — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Alessandra Fabi — Policlinico Gemelli
- Study coordinator: Alessandra Fabi
- Email: alessandra.fabi@policlinicogemelli.it
- Phone: 0630157337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Chemotherapy Effect, Triple Negative Breast Cancer, Recurrence, Local Neoplasm, Risk Factors