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Completed

NCT Number: NCT03002766

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

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.

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Key information

Conditions

Carcinoma Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Massimiliano Gennaro

Milan, MI, 20133, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Breast conservative surgery

Procedure

Primary outcomes

  1. Ipsilateral Breast Tumor Recurrence (IBTR)

    Time frame: six years

Secondary outcomes

  1. Contralateral breast cancer (CBC)

    Time frame: six years

    the side effects of radiotherapy may outweigh the reduction in the risk of IBTR

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Registry information

Official study 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

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Dec 26, 2016
Registry last updated
Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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