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

Breast-conserving Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06429644
• Other study ID #: 2022-04-039
• Status: Completed
• Start date: July 7, 2022
• Est. completion date: April 8, 2024

Study information

• Verified date: April 2024
• Source: Hanyang University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4010
• Est. completion date: April 8, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1/2 Mutation
• Breast-conserving Surgery

Intervention

Procedure:
• Breast-conserving surgery
Breast-conserving surgery, also known as breast-conserving therapy or lumpectomy, is a surgical procedure used to treat breast cancer while preserving as much of the breast tissue as possible. During this procedure, the surgeon removes the cancerous tumor along with a surrounding margin of normal tissue. The goal is to remove the cancerous cells while maintaining the appearance and function of the breast as much as possible.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang university hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital	Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group, Korean Surgical Society

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Locoregional recurrence-free survival	Recurrence in breast or chest wall and/or regional lymph nodes	Duration from diagnosis until the development of recurrence up to 10year
Primary	Distant recurrence-free survival	Recurrence in a distant organ	Duration from diagnosis until the development of recurrence up to 10year
Primary	Recurrence-free survival	Any form of disease recurrence	Duration from diagnosis until the development of recurrence up to 10year