Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07613151

Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lobular Breast Carcinoma Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Upfront Breast Surgery

Procedure

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

Primary outcomes

  1. Clinicopathological characterization of apocrine invasive lobular breast carcinoma

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

    Measured by descriptive analysis of tumor size, grade, nodal status, ER, PgR, HER2, Ki-67, androgen receptor, stage, histological features and treatment received.

Secondary outcomes

  1. Disease-Free Survival

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

  2. Overall Survival

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

  3. Recurrence Rate

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

    Measured as local, regional or distant recurrence.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniele Passeri, MD

CONTACT

[email protected]

+39 333 383 9397

Massimo Ferrucci, MD PhD

CONTACT

[email protected]

049 821 5500

Sponsors and collaborators

Lead sponsor

Istituto Oncologico Veneto IRCCS

Other

Registry information

Official study title

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

Acronym: NAPOLI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.