Predictive Model of Axillary Nodal Status After Neoadjuvant Chemotherapy in Breast Cancer Patients

NCT05798806 | Active Not Recruiting

• 1 other identifier: 2394
• Study Type: observational
• Target: 1,950
• Locations: 1 country
• Sites: 1

Brief Summary

The management of patients diagnosed with breast cancer (BC) with axillary nodal involvement is still a controversial topic. These patients' treatment usually involves the administration of a neoadjuvant chemotherapy (NAC) in order to improve survival rates and increase local disease control. Depending on the tumor subtype, an axillary pathologic complete response (pCR) is achieved in 40-70% of initially axillary node-positive patients (cN+). Concerning patients with an axillary pCR, thus a clinically negative node status (cN0), axillary lymphadenectomy (ALND) might be replaced by less invasive surgical approaches and sentinel lymph node biopsy (SLNB) is considered, in these cases, an effective alternative treatment. However, the relatively high false negative rates, reported in several validation trials, points out the complexity concerning these patients' treatment. Moreover, histological findings' predictive and prognostic value, after SLNB, of micrometastases and isolated tumor cells (ITCs) is still unclear. Currently, dual-tracer-guided lymph node biopsy and the surgical removal of ≥ 3 sentinel lymph nodes are known as effective strategies aimed to reduce the false negative rates. There are several ongoing clinical trials to understand and define the best approach for these patients. Nowadays, there's great interest in potential prognostic role of systemic inflammation's biochemical markers such as neutrophil-to-lymphocyte ratio (NLR). Systemic inflammation's markers may be nodal pCR's predictors after NAC in node-positive breast cancer patients. The aim of the study is to develop and validate a pre-operative model, able to predict pCR after NAC to select the patients suitable for a surgery de-escalation strategy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Selection of features

  Identification of pre-operative clinical-pathological features predictive for ypN0 status after NAC in patients with cN+ breast cancer (Logistic regression model will be performed)

  48 months

• Nomogram

  Development and validation of a nomogram, based on selected clinical-pathological features, able to predict nodal status after neoadjuvant chemotherapy

  48 months

Study Arms (1)

Patients with diagnosis of cN+ breast cancer who underwent neoadjuvant treatment

Patients with diagnosis of cN+ breast cancer who underwent neoadjuvant treatment and then treated with lymph node biopsy or axillary lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Breast cancer is gender based
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study involves patients with diagnosis of cN+ breast cancer who underwent neoadjuvant chemotherapy and afterwards treated with lymph node biopsy or axillary lymphadenectomy, referring to the participating centers.

You may qualify if:

• Diagnosis of breast cancer confirmed by histological examination
• Patients who underwent neoadjuvant chemotherapy
• Axillary lymph nodes involvement at diagnosis (cN≥1), identified by clinical examination and/or imaging techniques and/or axillary lymph node cytology aspirate positive for breast cancer cells.

You may not qualify if:

• Patients with M+ at diagnosis
• Contraindications for neoadjuvant chemotherapy

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

• Gasparri ML, Albasini S, Truffi M, Favilla K, Tagliaferri B, Piccotti F, Bossi D, Armatura G, Calcinotto A, Chiappa C, Combi F, Curcio A, Della Valle A, Ferrari G, Folli S, Ghilli M, Listorti C, Mancini S, Marinello P, Mele S, Pertusati A, Roncella M, Rossi L, Rovera F, Segattini S, Sgarella A, Tognali D, Corsi F. Low neutrophil-to-lymphocyte ratio and pan-immune-inflammation-value predict nodal pathologic complete response in 1274 breast cancer patients treated with neoadjuvant chemotherapy: a multicenter analysis. Ther Adv Med Oncol. 2023 Sep 15;15:17588359231193732. doi: 10.1177/17588359231193732. eCollection 2023.

  PMID: 37720495 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 5, 2023
• Study Start: February 4, 2020
• Primary Completion: May 25, 2021
• Study Completion (Estimated): January 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2025-05

Locations

IT (1)