Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,063

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2023

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

October 15, 2023

Completed

18 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed

13 days until next milestone

First Posted

Study publicly available on registry

November 15, 2023

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed

Last Updated

April 1, 2026

Status Verified

November 1, 2023

Enrollment Period

1.2 years

First QC Date

November 2, 2023

Last Update Submit

March 27, 2026

Conditions

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

Outcome Measures

Primary Outcomes (2)

Recurrence rate
Recurrence rate (both invasive and LCIS, any type)
From date of surgery until the date of first documented recurrence, assessed up to 120 months
Upgrade rate to invasive carcinoma
Upgrade rate from PLCIS and/or FLCIS to invasive carcinoma from diagnostic core-biopsy to final specimen histology
From date of diagnostic core biopsy until the date of final pathology report after surgery, assessed up to 6 months

Secondary Outcomes (5)

Overall Survival (OS)
From date of surgery until the date of last follow-up or date of death from any cause, whichever came first, assessed up to 120 months
Disease-free survival (DFS)
From date of surgery until the date of first recurrence, whenever occurred, assessed up to 120 months
Rate of re-operation and/or radiotherapy boost and/or clinical follow-up after "close" or involved resection margins being reported
From date of surgery until the date of surgical margins management completion (any potential clinical follow-up included), assessed up to 72 months
Postoperative complications
From date of surgery until any post-operative complications are resolved, assessed up to 3 months
Rate of adjuvant therapies utilization
From date of surgery until the date of adjuvant therapies completion, assessed up to 120 months

Study Arms (2)

Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast

Patients with diagnosis of pure pleomorphic lobular carcinoma in situ of the breast

Procedure: Surgical wide local excisionProcedure: Cavity shavingProcedure: Excision margin surgical clearanceRadiation: Adjuvant RadiotherapyBiological: Adjuvant Hormone Therapy

Florid Lobular Carcinoma in Situ (FLCIS) of the breast

Patients with diagnosis of pure florid lobular carcinoma in situ of the breast

Procedure: Surgical wide local excisionProcedure: Cavity shavingProcedure: Excision margin surgical clearanceRadiation: Adjuvant RadiotherapyBiological: Adjuvant Hormone Therapy