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

Completed

• Conditions: BRCA1/2 Mutation; Breast-conserving Surgery

• Registration Number: NCT06429644
• Lead Sponsor: Hanyang University Seoul Hospital

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.

Study Timeline

• Study Start: 2022-07-07
• Primary Completion: 2023-12-31
• Status Verified: 2024-04
• Study Completion: 2024-04-08
• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-23
• Last Update Submitted: 2024-05-23
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 4010

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Locoregional recurrence-free survival	Duration from diagnosis until the development of recurrence up to 10year	Recurrence in breast or chest wall and/or regional lymph nodes
Distant recurrence-free survival	Duration from diagnosis until the development of recurrence up to 10year	Recurrence in a distant organ
Recurrence-free survival	Duration from diagnosis until the development of recurrence up to 10year	Any form of disease recurrence

Trial Locations

Locations (1)

Hanyang university hospital; 🇰🇷 Seoul, Korea, Republic of