CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,063 enrolled
Drug / intervention
Adjuvant Hormone Therapy +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06133465
NCT06133465N/ACompleted

Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.

Istituto Oncologico Veneto IRCCS·observational·Posted Nov 15, 2023·Updated Apr 1, 2026

In Brief

An observational study evaluating Surgical wide local excision, Cavity shaving, and 3 other interventions for Pleomorphic Lobular Breast Carcinoma in Situ and Breast Florid Lobular Carcinoma in Situ. Completed, enrolled 1,063 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedNov 15, 2023
Enrollment StartOct 15, 2023
Primary CompletionDec 31, 2024
Study CompletionJan 31, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.6 years ago

Interventions

Surgical wide local excisionprocedure

Surgical excision of breast carcinoma

Cavity shavingprocedure

Cavity shaving of resection margins to guarantee oncological safety

Excision margin surgical clearanceprocedure

Surgical clearance of involved and/or closed excision margins

Adjuvant Radiotherapyradiation

Adjuvant radiotherapy

Adjuvant Hormone Therapybiological

Adjuvant hormone therapy