Clinical trial

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

Name
22171
Description
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 arms
Trial start
2023-10-15
Estimated PCD
2024-04-30
Trial end
2024-07-31
Status
Recruiting
Treatment
Surgical wide local excision
Surgical excision of breast carcinoma
Arms:
Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Cavity shaving
Cavity shaving of resection margins to guarantee oncological safety
Arms:
Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Excision margin surgical clearance
Surgical clearance of involved and/or closed excision margins
Arms:
Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Adjuvant Radiotherapy
Adjuvant radiotherapy
Arms:
Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Adjuvant Hormone Therapy
Adjuvant hormone therapy
Arms:
Florid Lobular Carcinoma in Situ (FLCIS) of the breast, Pleomorphic Lobular Carcinoma in Situ (PLCIS) of the breast
Size
250
Primary endpoint
Recurrence rate
From date of surgery until the date of first documented recurrence, assessed up to 120 months
Upgrade rate to invasive carcinoma
From date of diagnostic core biopsy until the date of final pathology report after surgery, assessed up to 6 months
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

1 product

1 indication