Clinical trial · Observational
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Florid Lobular Carcinoma in Situ | Breast Florid Lobular Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Pleomorphic Lobular Breast Carcinoma in Situ | Breast Pleomorphic Lobular Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Hormone Therapy | Biological | — | UNRESOLVED |
| Adjuvant Radiotherapy | Radiation | — | UNRESOLVED |
| Cavity shaving | Procedure | — | UNRESOLVED |
| Excision margin surgical clearance | Procedure | — | UNRESOLVED |
| Surgical wide local excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
- description
- Patients with diagnosis of pure pleomorphic lobular carcinoma in situ of the breast
- interventionNames
- Procedure: Surgical wide local excision
- Procedure: Cavity shaving
- Procedure: Excision margin surgical clearance
- Radiation: Adjuvant Radiotherapy
- Biological: Adjuvant Hormone Therapy
- label
- Florid Lobular Carcinoma in Situ (FLCIS) of the breast
- description
- Patients with diagnosis of pure florid lobular carcinoma in situ of the breast
- interventionNames
- Procedure: Surgical wide local excision
- Procedure: Cavity shaving
- Procedure: Excision margin surgical clearance
- Radiation: Adjuvant Radiotherapy
- Biological: Adjuvant Hormone Therapy
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of PLCIS and/or FLCIS of the breast on both core-biopsy and/or on final specimen histology; * Aged 18 years or older. Exclusion Criteria: * Histologic diagnosis of CLCIS; * Histologic diagnosis of LCIS (any type) associated with invasive carcinoma
References
Publications (17)
- BACKGROUNDLakhani S, Schnitt S, O'Malley F, et al. Lobular neoplasia. In: Lakhani S, Ellis I, Schnitt S, Tan P, van de Vijer M, eds. WHO Classification of Tumours of the Breast, 2nd ed. Lyon, France: International Agency for Research on Cancer; 2012:77-80
- BACKGROUNDPage DL, Schuyler PA, Dupont WD, Jensen RA, Plummer WD Jr, Simpson JF. Atypical lobular hyperplasia as a unilateral predictor of breast cancer risk: a retrospective cohort study. Lancet. 2003 Jan 11;361(9352):125-9. doi: 10.1016/S0140-6736(03)12230-1. PMID 12531579
- BACKGROUNDWen HY, Brogi E. Lobular Carcinoma In Situ. Surg Pathol Clin. 2018 Mar;11(1):123-145. doi: 10.1016/j.path.2017.09.009. Epub 2017 Dec 8. PMID 29413653
- BACKGROUNDFrost, A. R., T. N.Tsangaris, and S. G.Silverberg. Pleomorphic lobular carcinoma in situ. Pathol Case Rev 1996. 1:27-31.
- BACKGROUNDSneige N, Wang J, Baker BA, Krishnamurthy S, Middleton LP. Clinical, histopathologic, and biologic features of pleomorphic lobular (ductal-lobular) carcinoma in situ of the breast: a report of 24 cases. Mod Pathol. 2002 Oct;15(10):1044-50. doi: 10.1097/01.MP.0000027624.08159.19. PMID 12379750
- BACKGROUNDShin, S. J., R. A.DeLellis, D. M.Knowles, et al. "Florid" lobular carcinoma in situ with necrosis and calcification: a clinicopathologic, immunohistochemical and molecular analysis. Mod Pathol 2002. 15:52A.
- BACKGROUNDShin SJ, Lal A, De Vries S, Suzuki J, Roy R, Hwang ES, Schnitt SJ, Waldman FM, Chen YY. Florid lobular carcinoma in situ: molecular profiling and comparison to classic lobular carcinoma in situ and pleomorphic lobular carcinoma in situ. Hum Pathol. 2013 Oct;44(10):1998-2009. doi: 10.1016/j.humpath.2013.04.004. Epub 2013 Jun 25. PMID 23809857
- BACKGROUNDVos CB, Cleton-Jansen AM, Berx G, de Leeuw WJ, ter Haar NT, van Roy F, Cornelisse CJ, Peterse JL, van de Vijver MJ. E-cadherin inactivation in lobular carcinoma in situ of the breast: an early event in tumorigenesis. Br J Cancer. 1997;76(9):1131-3. doi: 10.1038/bjc.1997.523.