Pleomorphic Lobular Breast Carcinoma in SituNCT06133465
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management
An observational study of Pleomorphic Lobular Breast Carcinoma in Situ and Breast Florid Lobular Carcinoma in Situ, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleomorphic Lobular Breast Carcinoma in Situ, Breast Florid Lobular Carcinoma in Situ
- What is being tested?
- Surgical wide local excision, Cavity shaving and Excision margin surgical clearance
- Type of treatment
- Surgery or procedure
- How many people
- 1,063 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with pure variant pleomorphic and/or florid lobular carcinoma in situ of the breast
Who may be able to join
- 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.
Who cannot join
- Histologic diagnosis of CLCIS;
- Histologic diagnosis of LCIS (any type) associated with invasive carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.
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:
Read more
- 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.
Read the detailed description
Classical lobular carcinoma in situ (CLCIS) of the breast is considered a non-obligate precursor of invasive carcinoma. Histologically, it is categorized as a lesion with uncertain malignancy potential, and clinical management often parallels that of benign neoplastic conditions.
In contrast, its two variants, florid LCIS (FLCIS) and pleomorphic LCIS (PLCIS), have distinct morphological and genetic characteristics and a higher probability of being obligatory precursors to invasive carcinoma.
PLCIS shows marked cellular-nuclear pleomorphism, resembling high-grade ductal carcinoma in situ (often initially misdiagnosed as such).
FLCIS, on the other hand, displays a complete architectural subversion of lobular structure due to the increased rate of cell replication.
Both variants may show foci of comedonecrosis, a distinctive but not specific diagnostic feature.
A significant difference from CLCIS is their breast distribution; CLCIS tends to be multifocal, while the two variants typically present as unifocal.
Genetically, the two variants differ from CLCIS, with higher genetic instability, and increased alterations in genes coding for tumor suppressors and proteins involved in cell growth regulation and replication.
Immunohistochemically, both FLCIS and PLCIS regularly express estrogen and progesterone receptors, and they may present higher HER2 (Human Epidermal growth factor Receptor 2 - ERBB2 gene) over-expression compared to CLCIS.
Many controversies persist in the clinical management of these variants, largely due to their rarity in pure, isolated forms. Often, they are associated with an invasive carcinoma, which becomes the primary therapeutic focus, according to well established treatment protocols. Dedicated studies, both prospective and retrospective, are completely lacking in the literature, especially for pure FLCIS. Consequently, there is no consensus or approved international guidelines for accurate diagnostic-therapeutic strategies. Even the histological categorization of biopsy tests still remains a subject of debate.
Presently, there is unanimous consensus on the indication for surgical excision of these lesions to improve histological definition and exclude the presence of an invasive neoplastic focus. However, there is no consensus on the need of surgical margins cavity shaving and the management of resection margins when they are proved to be close or involved at the final specimen pathological report. Furthermore, there is a lack of evidence-based recommendations for adjuvant therapies like radiotherapy or endocrine therapy. Some scientific international associations, such as ESMO (European Society of Medical Oncology), suggest a similar approach to pleomorphic variants as for ductal carcinoma in situ due to their morphological similarity; yet, in the absence of robust evidence, this stance does not definitively support the benefit of adjuvant therapeutic strategies and poses a relative risk of overtreatment.
To address these challenges, the investigators propose international multicenter retrospective collection of cases involving the pure forms of FLCIS and PLCIS. Our goal is to comprehensively analyze the diagnostic and therapeutic management of this specific patient group and, notably, to fill the gap in the scientific literature regarding their treatment.
- Being tested
- Surgical wide local excision, Cavity shaving, Excision margin surgical clearance, Adjuvant Radiotherapy, Adjuvant Hormone Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical wide local excisionProcedure or surgery
Surgical excision of breast carcinoma
Cavity shavingProcedure or surgery
Cavity shaving of resection margins to guarantee oncological safety
Excision margin surgical clearanceProcedure or surgery
Surgical clearance of involved and/or closed excision margins
Adjuvant RadiotherapyRadiation
Adjuvant radiotherapy
Adjuvant Hormone TherapyBiological
Adjuvant hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast | Patients with diagnosis of pure pleomorphic lobular carcinoma in situ of the breast Receives: Procedure: Surgical wide local excision; Procedure: Cavity shaving; Procedure: Excision margin surgical clearance; Radiation: Adjuvant Radiotherapy; Biological: 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 Receives: Procedure: Surgical wide local excision; Procedure: Cavity shaving; Procedure: Excision margin surgical clearance; Radiation: Adjuvant Radiotherapy; Biological: Adjuvant Hormone Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Recurrence rate (both invasive and LCIS, any type)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Management of involved and/or closed surgical resection margins
Measured: 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
Incidence and management of post-operative complications
Measured: From date of surgery until any post-operative complications are resolved, assessed up to 3 months
Rate of adjuvant therapies utilization
Adjuvant therapies and associated side effects
Measured: From date of surgery until the date of adjuvant therapies completion, assessed up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Pleomorphic Lobular Breast Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,063 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferrucci Massimo, Istituto Oncologico Veneto IRCCS
- Investigators
- Massimo Ferrucci, MD PhD, Principal investigator, Istituto Oncologico Veneto IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133465
- Sponsor's protocol ID
- 22171
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lakhani 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
Page 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.
PubMed 12531579Wen 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.
PubMed 29413653Frost, A. R., T. N.Tsangaris, and S. G.Silverberg. Pleomorphic lobular carcinoma in situ. Pathol Case Rev 1996. 1:27-31.
Sneige 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.
PubMed 12379750Shin, 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.
Shin 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.
PubMed 23809857Vos 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.
PubMed 9365159Bratthauer GL, Moinfar F, Stamatakos MD, Mezzetti TP, Shekitka KM, Man YG, Tavassoli FA. Combined E-cadherin and high molecular weight cytokeratin immunoprofile differentiates lobular, ductal, and hybrid mammary intraepithelial neoplasias. Hum Pathol. 2002 Jun;33(6):620-7. doi: 10.1053/hupa.2002.124789.
PubMed 12152161Goldstein NS, Kestin LL, Vicini FA. Clinicopathologic implications of E-cadherin reactivity in patients with lobular carcinoma in situ of the breast. Cancer. 2001 Aug 15;92(4):738-47.
PubMed 11550142Jacobs TW, Pliss N, Kouria G, Schnitt SJ. Carcinomas in situ of the breast with indeterminate features: role of E-cadherin staining in categorization. Am J Surg Pathol. 2001 Feb;25(2):229-36. doi: 10.1097/00000478-200102000-00011.
PubMed 11176072Maluf HM, Swanson PE, Koerner FC. Solid low-grade in situ carcinoma of the breast: role of associated lesions and E-cadherin in differential diagnosis. Am J Surg Pathol. 2001 Feb;25(2):237-44. doi: 10.1097/00000478-200102000-00012.
PubMed 11176073Sullivan ME, Khan SA, Sullu Y, Schiller C, Susnik B. Lobular carcinoma in situ variants in breast cores: potential for misdiagnosis, upgrade rates at surgical excision, and practical implications. Arch Pathol Lab Med. 2010 Jul;134(7):1024-8. doi: 10.5858/2009-0300-OA.1.
PubMed 20586632Chen YY, Hwang ES, Roy R, DeVries S, Anderson J, Wa C, Fitzgibbons PL, Jacobs TW, MacGrogan G, Peterse H, Vincent-Salomon A, Tokuyasu T, Schnitt SJ, Waldman FM. Genetic and phenotypic characteristics of pleomorphic lobular carcinoma in situ of the breast. Am J Surg Pathol. 2009 Nov;33(11):1683-94. doi: 10.1097/PAS.0b013e3181b18a89.
PubMed 19701073Bagaria SP, Shamonki J, Kinnaird M, Ray PS, Giuliano AE. The florid subtype of lobular carcinoma in situ: marker or precursor for invasive lobular carcinoma? Ann Surg Oncol. 2011 Jul;18(7):1845-51. doi: 10.1245/s10434-011-1563-0. Epub 2011 Feb 2.
PubMed 21287281
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management. A Multicenter Observational Retrospective Study.
- ClinicalTrials.gov ID
- NCT06133465
- Acronym / sponsor ID
- 22171
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,063 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Classical lobular carcinoma in situ (CLCIS) of the breast is considered a non-obligate precursor of invasive carcinoma. Histologically, it is categorized as a lesion with uncertain malignancy potential, and clinical management often parallels that of benign neoplastic conditions.
In contrast, its two variants, florid LCIS (FLCIS) and pleomorphic LCIS (PLCIS), have distinct morphological and genetic characteristics and a higher probability of being obligatory precursors to invasive carcinoma.
PLCIS shows marked cellular-nuclear pleomorphism, resembling high-grade ductal carcinoma in situ (often initially misdiagnosed as such).
FLCIS, on the other hand, displays a complete architectural subversion of lobular structure due to the increased rate of cell replication.
Both variants may show foci of comedonecrosis, a distinctive but not specific diagnostic feature.
A significant difference from CLCIS is their breast distribution; CLCIS tends to be multifocal, while the two variants typically present as unifocal.
Genetically, the two variants differ from CLCIS, with higher genetic instability, and increased alterations in genes coding for tumor suppressors and proteins involved in cell growth regulation and replication.
Immunohistochemically, both FLCIS and PLCIS regularly express estrogen and progesterone receptors, and they may present higher HER2 (Human Epidermal growth factor Receptor 2 - ERBB2 gene) over-expression compared to CLCIS.
Many controversies persist in the clinical management of these variants, largely due to their rarity in pure, isolated forms. Often, they are associated with an invasive carcinoma, which becomes the primary therapeutic focus, according to well established treatment protocols. Dedicated studies, both prospective and retrospective, are completely lacking in the literature, especially for pure FLCIS. Consequently, there is no consensus or approved international guidelines for accurate diagnostic-therapeutic strategies. Even the histological categorization of biopsy tests still remains a subject of debate.
Presently, there is unanimous consensus on the indication for surgical excision of these lesions to improve histological definition and exclude the presence of an invasive neoplastic focus. However, there is no consensus on the need of surgical margins cavity shaving and the management of resection margins when they are proved to be close or involved at the final specimen pathological report. Furthermore, there is a lack of evidence-based recommendations for adjuvant therapies like radiotherapy or endocrine therapy. Some scientific international associations, such as ESMO (European Society of Medical Oncology), suggest a similar approach to pleomorphic variants as for ductal carcinoma in situ due to their morphological similarity; yet, in the absence of robust evidence, this stance does not definitively support the benefit of adjuvant therapeutic strategies and poses a relative risk of overtreatment.
To address these challenges, the investigators propose international multicenter retrospective collection of cases involving the pure forms of FLCIS and PLCIS. Our goal is to comprehensively analyze the diagnostic and therapeutic management of this specific patient group and, notably, to fill the gap in the scientific literature regarding their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast | – | Procedure: Surgical wide local excision, Procedure: Cavity shaving, Procedure: Excision margin surgical clearance, Radiation: Adjuvant Radiotherapy, Biological: Adjuvant Hormone TherapyPatients with diagnosis of pure pleomorphic lobular carcinoma in situ of the breast |
| Florid Lobular Carcinoma in Situ (FLCIS) of the breast | – | Procedure: Surgical wide local excision, Procedure: Cavity shaving, Procedure: Excision margin surgical clearance, Radiation: Adjuvant Radiotherapy, Biological: Adjuvant Hormone TherapyPatients with diagnosis of pure florid lobular carcinoma in situ of the breast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pure variant pleomorphic and/or florid lobular carcinoma in situ of the breast
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Histologic diagnosis of CLCIS;
- Histologic diagnosis of LCIS (any type) associated with invasive carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical wide local excisionSurgical excision of breast carcinoma | Procedure or surgery | Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast |
| Cavity shavingCavity shaving of resection margins to guarantee oncological safety | Procedure or surgery | Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast |
| Excision margin surgical clearanceSurgical clearance of involved and/or closed excision margins | Procedure or surgery | Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast |
| Adjuvant RadiotherapyAdjuvant radiotherapy | Radiation | Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast |
| Adjuvant Hormone TherapyAdjuvant hormone therapy | Biological | Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast |
Primary outcome
Recurrence rate
Time frame: From date of surgery until the date of first documented recurrence, assessed up to 120 months
Recurrence rate (both invasive and LCIS, any type)
Upgrade rate to invasive carcinoma
Time frame: From date of diagnostic core biopsy until the date of final pathology report after surgery, assessed up to 6 months
Upgrade rate from PLCIS and/or FLCIS to invasive carcinoma from diagnostic core-biopsy to final specimen histology
5 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From date of surgery until any post-operative complications are resolved, assessed up to 3 months
Rate of adjuvant therapies utilization
Time frame: From date of surgery until the date of adjuvant therapies completion, assessed up to 120 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- 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
- Background: PubMed 12531579Page 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.
- Background: PubMed 29413653Wen 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.
- BackgroundFrost, A. R., T. N.Tsangaris, and S. G.Silverberg. Pleomorphic lobular carcinoma in situ. Pathol Case Rev 1996. 1:27-31.
- Background: PubMed 12379750Sneige 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.
- 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.
- Background: PubMed 23809857Shin 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.
- Background: PubMed 9365159Vos 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.
- Background: PubMed 12152161Bratthauer GL, Moinfar F, Stamatakos MD, Mezzetti TP, Shekitka KM, Man YG, Tavassoli FA. Combined E-cadherin and high molecular weight cytokeratin immunoprofile differentiates lobular, ductal, and hybrid mammary intraepithelial neoplasias. Hum Pathol. 2002 Jun;33(6):620-7. doi: 10.1053/hupa.2002.124789.
- Background: PubMed 11550142Goldstein NS, Kestin LL, Vicini FA. Clinicopathologic implications of E-cadherin reactivity in patients with lobular carcinoma in situ of the breast. Cancer. 2001 Aug 15;92(4):738-47.
- Background: PubMed 11176072Jacobs TW, Pliss N, Kouria G, Schnitt SJ. Carcinomas in situ of the breast with indeterminate features: role of E-cadherin staining in categorization. Am J Surg Pathol. 2001 Feb;25(2):229-36. doi: 10.1097/00000478-200102000-00011.
- Background: PubMed 11176073Maluf HM, Swanson PE, Koerner FC. Solid low-grade in situ carcinoma of the breast: role of associated lesions and E-cadherin in differential diagnosis. Am J Surg Pathol. 2001 Feb;25(2):237-44. doi: 10.1097/00000478-200102000-00012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Ferrucci, MD PhD principal investigator
Istituto Oncologico Veneto IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleomorphic Lobular Breast Carcinoma in Situ and Breast Florid Lobular Carcinoma in Situ, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: From date of surgery until the date of first documented recurrence, assessed up to 120 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133465, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.