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

ConditionLobular Breast Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Oncologico Veneto IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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)

Trial population

Patients diagnosed between January 1, 2010 and December 31, 2025 will be included. Follow-up will be collected until the most recent available clinical update.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Upfront Breast Surgery

    Procedure/Surgery

    Upfront Conservative or Demolitive Breast Surgery

  • Adjuvant Radiotherapy

    Radiation

    Adjuvant Breast or Chest Wall Radiotherapy after Breast Surgery

  • Endocrine Therapy

    Drug

    Adjuvant or Neoadjuvant Endocrine Therapy

  • Chemotherapy

    Drug

    Adjuvant or Neoadjuvant Chemotherapy

Treatment groups

250 Participants
are divided into 4 treatment groups
Group A: Triple-negative ILC4 interventions
Group B: HER2-positive ILC4 interventions
Group C: HR-low ILC (cross-cutting category)4 interventions
Group D: Exploratory Subgroups (cross-cutting category)4 interventions

Trial outcomes

Primary outcomes

1

Invasive disease-free survival (iDFS)

Time from definitive surgery to first invasive event (ipsilateral invasive, locoregional invasive, or distant recurrence, contralateral invasive BC)

Time frame
Through study completion, an average of 5 years

Secondary outcomes

1

Overall survival (OS)

Time frame
Through study completion, an average of 5 years
2

Distant disease-free survival (DDFS)

Time frame
Through study completion, an average of 5 years
3

Breast cancer-specific survival (BCSS)

Time frame
Through study completion, an average of 5 years
4

Locoregional recurrence-free survival (LRRFS)

Time frame
Through study completion, an average of 5 years

Other outcomes

1

Pathologic complete response (pCR) - ypT0/Tis ypN0, with residual cancer burden (RCB) class distribution; in the neoadjuvant cohort, event-free survival (EFS) from treatment initiation where data permit

Time frame
Through study completion, an average of 5 years
2

Multidisciplinary treatment patterns and treatment-related outcomes according to therapeutic strategy (upfront surgery versus neoadjuvant treatment), surgical management (including reconstruction/oncoplastic approaches), systemic and radiation therapy

Time frame
Through study completion, an average of 5 years
3

Prognostic, predictive and potential therapeutic relevance of clinicopathologic, molecular, and biologic features

Somatic and germline alterations, TME features (stromal TILs, PD-L1 status, immune-related biomarkers), apocrine differentiation, LAR phenotype, HER2 status, HR-negative versus HR-low status, and classic versus pleomorphic/non-classic ILC variants

Time frame
Through study completion, an average of 5 years
4

Biomarker-outcome associations with iDFS, pCR and OS

Time frame
Through study completion, an average of 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Oncologico Veneto IRCCS

Lead sponsor

Source ClinicalTrials.gov
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