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

Primary Purpose

Carcinoma Breast

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Breast conservative surgery
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma Breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Massimiliano Gennaro

Outcomes

Primary Outcome Measures

Ipsilateral Breast Tumor Recurrence (IBTR)

Secondary Outcome Measures

Contralateral breast cancer (CBC)
the side effects of radiotherapy may outweigh the reduction in the risk of IBTR

Full Information

First Posted
December 2, 2016
Last Updated
December 21, 2016
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT03002766
Brief Title
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast
Acronym
DCIS
Official Title
Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2000 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Breast conservative surgery
Primary Outcome Measure Information:
Title
Ipsilateral Breast Tumor Recurrence (IBTR)
Time Frame
six years
Secondary Outcome Measure Information:
Title
Contralateral breast cancer (CBC)
Description
the side effects of radiotherapy may outweigh the reduction in the risk of IBTR
Time Frame
six years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimiliano Gennaro, MD
Organizational Affiliation
Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massimiliano Gennaro
City
Milano
State/Province
MI
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

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

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