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NCT06133465
Pure Florid and Pleomorphic Lobular Carcinoma in Situ of the Breast: Towards an Increasingly Uniform Management
trial testing Surgical wide local excision in Pleomorphic Lobular Breast Carcinoma in Situ in 1,063 participants. Completed in 31 January 2025.
31 December 2024
Quick facts
| Lead sponsor | Istituto Oncologico Veneto IRCCS |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,063 |
| Start date | 15 October 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 January 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Surgical wide local excision
- Cavity shaving
- Excision margin surgical clearance
- Adjuvant Radiotherapy
- Adjuvant Hormone Therapy — full drug profile →
Conditions studied
- Pleomorphic Lobular Breast Carcinoma in Situ — all drugs for Pleomorphic Lobular Breast Carcinoma in Situ →
- Breast Florid Lobular Carcinoma in Situ — all drugs for Breast Florid Lobular Carcinoma in Situ →
Sponsor
Istituto Oncologico Veneto IRCCS — full company profile →
Who can join
18 and older, any sex, with Pleomorphic Lobular Breast Carcinoma in Situ or Breast Florid Lobular Carcinoma in Situ. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06133465
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06133465 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Oncologico Veneto IRCCS
- Last refreshed: 1 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06133465.
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