RecruitingNCT07613151

Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer

NAPOLI Study: Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer - A Retrospective Multicenter Observational Study


Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

250 participants

Start Date

May 1, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

The NAPOLI Study is a retrospective multicenter observational study designed to characterize negative hormone receptor and apocrine lobular invasive breast cancer. 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

Min Age: 18 Years

Inclusion Criteria7

  • Female or male patients aged ≥18 years.
  • Histologically confirmed invasive lobular carcinoma of the breast.
  • Presence of apocrine differentiation/features documented in pathology report or confirmed by local pathology review.
  • Negative hormone receptors.
  • Diagnosis and/or treatment at one of the participating centers.
  • Availability of essential clinicopathological data.
  • Availability of follow-up data, when applicable.

Exclusion Criteria5

  • Pure ductal carcinoma without lobular invasive component.
  • Metastatic tumor to the breast from non-breast primary cancer.
  • Insufficient pathological documentation to confirm eligibility.
  • Missing essential clinical data.
  • Patients who denied consent for retrospective data use, where applicable by local regulations.

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Interventions

PROCEDUREUpfront Breast Surgery

Upfront Conservative or Demolitive Breast Surgery

RADIATIONAdjuvant Radiotherapy

Adjuvant Breast or Chest Wall Radiotherapy after Breast Surgery

DRUGEndocrine Therapy

Adjuvant or Neoadjuvant Endocrine Therapy

DRUGChemotherapy

Adjuvant or Neoadjuvant Chemotherapy


Locations(1)

Veneto Institute of Oncology

Padova, Italy

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NCT07613151


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