Clinical trial NCT03002766: Ten Years Results of a Score System to Address Adjuvant Therapies After Breast Conserving Surgery for Ductal Carcinoma in Situ of the Breast
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma Breast
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Ipsilateral Breast Tumor Recurrence (IBTR)
timeFrame: six years
Secondary outcomes:
measure: Contralateral breast cancer (CBC)
timeFrame: six years
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Massimiliano Gennaro
state: MI
Study officials:
affiliation: Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
name: Massimiliano Gennaro, MD
role: PRINCIPAL_INVESTIGATOR
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