Recruiting
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
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.
ClinicalTrials.gov IDNCT07613151
PhaseNot Applicable
Enrollment250
SponsorIstituto Oncologico Veneto IRCCS
Age18 Years
SexALL
Conditions studied
Lobular Breast Carcinoma
About this study
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.
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
Primary outcomes
- Invasive disease-free survival (iDFS) (Through study completion, an average of 5 years)
Eligibility information
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
Study locations
- Veneto Institute of Oncology, Padova, Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.