Evaluation of Recurrence Risk Factors in Locally Advanced Breast Cancer Patients Underwent Neoadjuvant Chemotherapy.

NCT06441240 | Recruiting

• 1 other identifier: 6081
• Study Type: observational
• Target: 933
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION Breast cancer (BC) is the leading cause of cancer-related death in women. Since the early 1980s, the implementation of screening programs has reduced the number of patients diagnosed with locally advanced breast cancer. Currently, the treatment for these patients involves initial neoadjuvant chemotherapy (NACT) followed by surgical treatment. In recent years, NACT has also been used for highly chemoresponsive tumors such as triple-negative (TN) and HER2-positive (HER2+) breast cancer. The widespread use of NACT has led to additional benefits, including downstaging of breast and axillary neoplasms, resulting in reduced morbidity; improved cosmetic outcomes due to increased use of conservative interventions; and personalized adjuvant chemotherapy treatment. Several studies have shown that response to chemotherapy predicts better systemic outcomes. Complete pathological response (pCR), defined as the absence of invasive neoplastic residue in the surgical specimen, has been predictive of better distant outcomes. Limited evidence exists regarding other predictive factors for distant outcomes. Given the significant impact of disease recurrence on patient prognosis, efforts have been made to understand the factors contributing to recurrence and to predict which patients are more prone to relapse. In this context, the term "Early Disease Recurrence" (EDR) has been coined to define the occurrence of disease recurrence, both locally and distantly, within 3 years after completing treatment. In recent years, the potential of radiomic analysis in aiding diagnostic and therapeutic decision-making processes in BC has been demonstrated. Specifically, radiomic features obtained from Magnetic Resonance Imaging (MRI) images appear capable of predicting tumor receptor status, differentiating tumor subtypes, and predicting response to NACT. Although the role of radiomics in predicting recurrence has been investigated, research is still in its early stages, and there are variations in technology and methodology for extracting radiomic features. Additionally, to date, no studies have evaluated the feasibility and reliability of using radiomic models combined with clinical and radiological variables to predict disease recurrence in BC patients undergoing NACT.

Conditions

Breast Cancer; Chemotherapy Effect; Triple Negative Breast Cancer; Recurrence, Local Neoplasm; Risk Factors

Outcome Measures

Primary Outcomes (2)

• Description of molecular subtypes

  Frequency of molecular subtypes (Her2 positive, hormone receptor-positive/Her2 negative, Triple Negative) in the considered cases

  7 years

• Association between radiomic features and risk of recurrence

  Association between radiomic features extracted from pre-operative MRI and the onset of disease recurrence within 3 years from the end of neoadjuvant treatment

  7 years

Secondary Outcomes (7)

• Association between chemotherapy and neoplastic characteristics

  7 years

• Evaluation of radiological response

  7 years

• Frequency of complete pathological response

  7 years

• Description of surgical treatment according to the cancer characteristics

  7 years

• Description of adjuvant treatments

  7 years

Study Arms (1)

Breast cancer patients underwent neoadjuvant chemotherapy

Patients undergoing neoadjuvant chemotherapy and subsequent surgical treatment. Patients must have undergone radiological evaluation by MRI at the beginning and end of chemotherapy treatment

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Breast MRI

Breast cancer patients underwent neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with breast cancer (Stage I, II, and III) undergoing NACT at our center between January 2014 and June 2021 will be included, for an estimated total of 933 patients.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, Italy

RECRUITING

Related Publications (1)

• Antonio F, Carbognin L, Paris I, Di Leone A, Orlandi A, Marazzi F, Mule A, Belli P, Rossi A, Magno S, Palazzo A, Masiello V, Santoro A, Fuso P, Bria E, D'Archi S, Scardina L, Sanchez AM, Giannarelli D, Paternello S, Garganese G, Scambia G, Tortora G, Masetti R, Franceschini G, Fabi A. Predictive risk factors of recurrence in breast cancer after neoadjuvant treatment: the NEORISK study. Future Oncol. 2025 Jul;21(17):2215-2223. doi: 10.1080/14796694.2025.2516410. Epub 2025 Jun 14.

  PMID: 40515524 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasm Recurrence, Local

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alessandra Fabi

  Policlinico Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra Fabi

CONTACT

0630157337; alessandra.fabi@policlinicogemelli.it

Antonio Franco

CONTACT

0630157337; antonio.franco@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: June 4, 2024
• Study Start: November 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: March 30, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-04

Locations

IT (1)