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RECRUITING

NCT07613151

Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study

Sponsor: Istituto Oncologico Veneto IRCCS

View on ClinicalTrials.gov

Summary

The NAPOLI Study is a retrospective multicenter observational study designed to characterize hormone receptor-negative/low invasive lobular carcinoma of the breast. The study will collect real-world clinicopathological, molecular, therapeutic and outcome data from patients diagnosed and treated at participating centers. The aim is to describe the clinical behavior, pathological features, receptor profile, treatments received and oncologic outcomes of this rare breast cancer subtype.

Official title: NAPOLI: Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2026-05-01

Completion Date

2027-12-31

Last Updated

2026-09-02

Healthy Volunteers

Not specified

Conditions

Lobular Breast Carcinoma

Interventions

PROCEDURE

Upfront Breast Surgery

Upfront Conservative or Demolitive Breast Surgery

RADIATION

Adjuvant Radiotherapy

Adjuvant Breast or Chest Wall Radiotherapy after Breast Surgery

DRUG

Endocrine Therapy

Adjuvant or Neoadjuvant Endocrine Therapy

DRUG

Chemotherapy

Adjuvant or Neoadjuvant Chemotherapy

Inclusion Criteria: * Female or male patients aged ≥18 years; * Histologically confirmed ILC, confirmed by E-cadherin loss/aberrant expression and/or p120 cytoplasmic relocalization and/or CDH1 alteration; * HR-negative (ER \<1% and PR \<1%) or HR-low (ER and/or PR 1-10%) disease, as defined by ASCO/CAP guidelines, is eligible regardless of HER2 status (assessed according to 2025 ASCO/CAP criteria, with HER2-low and HER2-ultralow status recorded where assessable); * HR-positive (ER\>10% according to the ASCO/CAP guidelines) ILC is eligible only if HER2 status is positive; * Mixed ductal-lobular carcinomas are eligible provided that a clearly identified invasive lobular component is present and predominant (\>50% lobular) and HR-negative/low criteria are met; * Stage I-III disease at diagnosis; Patients with de novo stage IV disease who underwent surgery of the primary tumor will not be included in the main study cohort but may be captured in a separate exploratory cohort for dedicated analysis; * Patients who underwent surgery of the primary tumor at the participating institution, either upfront or after neoadjuvant systemic treatment; * Diagnosis occurred between 1 January 2000 and 31 December 2025; * Minimum follow-up of 12 months for patients without an event, unless recurrence or death occurred earlier; * Local review by a dedicated breast pathologist to confirm the diagnosis and the related molecular features, with particular attention to the confirmation of apocrine morphology. Exclusion Criteria: * Pure IC NST without any lobular invasive component; * ER or PR expression \>10% in the invasive component, in cases with negative HER2 status; * In situ lobular neoplasia (lobular carcinoma in situ) without an invasive component; * De novo stage IV disease (such patients, if they underwent surgery of the primary tumor, will be captured in a separate exploratory cohort for a dedicated analysis) * Synchronous invasive BC of another dominant histology requiring systemic treatment that precludes attribution of outcomes to HR-negative/low ILC; * Prior invasive BC under active systemic treatment at the time of diagnosis, unless clearly documented as unrelated and not expected to confound outcomes; * Insufficient data or follow up

Locations (1)

Veneto Institute of Oncology

Padova, Italy