Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast

Phase 2

Completed

• Conditions: Carcinoma Breast

• Registration Number: NCT03002766
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

By this non-randomized prospective study, it's evaluated the outcome of patients underwent BCS for DCIS at whom an established score system to address adjuvant therapies have been prospectively applied, according to the wideness of free margins.

Between March 2000 and April 2006, 224 patients were enrolled and followed within the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-21
• Last Update Submitted: 2016-12-21
• Study First Posted: 2016-12-26
• Last Update Posted: 2016-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• age >18 years;
• female candidate to breast conservative surgery

Exclusion Criteria

• female with previous omolateral or controlateral breast cancer;
• female with previous radiotherapy (RT).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ipsilateral Breast Tumor Recurrence (IBTR)	six years

Secondary Outcome Measures

Name	Time	Method
Contralateral breast cancer (CBC)	six years	the side effects of radiotherapy may outweigh the reduction in the risk of IBTR

Trial Locations

Locations (1)

Massimiliano Gennaro; 🇮🇹 Milano, MI, Italy