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Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management

NCT06133465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1063

Last updated 2026-04-01

No results posted yet for this study

Summary

The goal of this retrospective multicenter observational study is to understand and evaluate the diagnostic and therapeutic management of pure forms of Florid Lobular Carcinoma In Situ (FLCIS) and Pleomorphic Lobular Carcinoma In Situ (PLCIS) of the breast. It addresses the significant challenges and controversies surrounding their clinical management, due to a lack of consensus or approved international guidelines.

The main questions this study aims to answer are:

* How is the diagnostic process for pure FLCIS and PLCIS currently managed?
* What are the primary therapeutic approaches for these specific breast conditions?
* How are positive and "close" surgical excision margins handled?
* Is adjuvant treatment, such as hormone therapy and radiotherapy, necessary?
* What factors are associated with recurrences?
* What are the rates of recurrences and/or upgrade to invasive carcinoma?

Participants will retrospectively collect all cases of pure FLCIS and PLCIS, reporting detailed data about their diagnostic and therapeutic management, as well as clinical and survival outcomes.

Methodology:

This international multicenter retrospective study will collect cases involving the pure forms of FLCIS and PLCIS of the breast. The study aims to provide insights into the current diagnostic and therapeutic approaches, along with the identification of opportunities to enhance clinical management, ultimately providing evidence-based recommendations and addressing the current lack of scientific literature regarding their treatment.

Conditions

  • Pleomorphic Lobular Breast Carcinoma in Situ
  • Breast Florid Lobular Carcinoma in Situ

Interventions

PROCEDURE

Surgical wide local excision

Surgical excision of breast carcinoma

PROCEDURE

Cavity shaving

Cavity shaving of resection margins to guarantee oncological safety

PROCEDURE

Excision margin surgical clearance

Surgical clearance of involved and/or closed excision margins

RADIATION

Adjuvant Radiotherapy

Adjuvant radiotherapy

BIOLOGICAL

Adjuvant Hormone Therapy

Adjuvant hormone therapy

Sponsors & Collaborators

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Principal Investigators

  • Massimo Ferrucci, MD PhD · Istituto Oncologico Veneto IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-15
Primary Completion
2024-12-31
Completion
2025-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06133465 on ClinicalTrials.gov