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Clinical Trials/NCT06429644
NCT06429644
Completed
Not Applicable

Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations

Hanyang University Seoul Hospital1 site in 1 country4,010 target enrollmentJuly 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
BRCA1/2 Mutation
Sponsor
Hanyang University Seoul Hospital
Enrollment
4010
Locations
1
Primary Endpoint
Recurrence-free survival
Status
Completed
Last Updated
last year

Overview

Brief Summary

The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients in breast cancer patients with BRCA 1/2 mutations.

Detailed Description

The purpose of study is to assess the oncologic safety of BCS in patients carrying BRCA1/2 mutations by comparing long-term outcomes with mastectomy. The investigators matched BCS and mastectomy group using propensity scores and analyzed the recurrence and survival among the evenly matched patients. By providing insights into the feasibility of BCS for patients with BRCA1/2 mutations, the investigators aim to present evidence to aid in surgical decision-making for the care of these patients.

Registry
clinicaltrials.gov
Start Date
July 7, 2022
End Date
April 8, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hanyang University Seoul Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primary invasive breast cancer who underwent BCS or mastectomy
  • Received a BRCA1/2 mutation test

Exclusion Criteria

  • Patients with de novo metastasis
  • Pregnancy-associated breast cancer

Outcomes

Primary Outcomes

Recurrence-free survival

Time Frame: Duration from diagnosis until the development of recurrence up to 10year

Any form of disease recurrence

Distant recurrence-free survival

Time Frame: Duration from diagnosis until the development of recurrence up to 10year

Recurrence in a distant organ

Locoregional recurrence-free survival

Time Frame: Duration from diagnosis until the development of recurrence up to 10year

Recurrence in breast or chest wall and/or regional lymph nodes

Study Sites (1)

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