## Protocol Section
### Identification Module
**NCT ID:** NCT06429644

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

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

#### Organization Study ID Info
**ID:** 2022-04-039
#### Organization
**Class:** OTHER
**Full Name:** Hanyang University Seoul Hospital
### Status Module
#### Completion Date
**Date:** 2024-04-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2022-07-07

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Korean Surgical Society

**Class:** UNKNOWN

**Name:** Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group

#### Lead Sponsor

**Class:** OTHER

**Name:** Hanyang University Seoul Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- BRCA1/2 Mutation

- Breast-conserving Surgery

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 4010

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University, Dongtan, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Dongtan Sacred Heart Hospital

#### Arm Group 2

**Description:** Division of Breast Surgery, Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Samsung Medical Center

#### Arm Group 3

**Description:** Breast Care Center, Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Seoul National University Hospital

#### Arm Group 4

**Description:** Department of Surgery, Severance hospital, Yonsei University College of Medicine, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Severance hospital

#### Arm Group 5

**Description:** Department of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Kyungpook National University Chilgok Hospital

#### Arm Group 6

**Description:** Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Gangnam Severance Hospital

#### Arm Group 7

**Description:** Department of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Hanyang University Medical Center

#### Arm Group 8

**Description:** Department of Breast \& Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Hallym University Sacred Heart Hospital

#### Arm Group 9

**Description:** Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Kangbuk Samsung Hospital

#### Arm Group 10

**Description:** Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Incheon St. Mary's Hospital

#### Arm Group 11

**Description:** Department of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Kyung Hee University Hospital

#### Arm Group 12

**Description:** Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Keimyung University School of Medicine

#### Arm Group 13

**Description:** Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea

**Intervention Names:**

- Procedure: Breast-conserving surgery

**Label:** Asan Medical Center

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Asan Medical Center

- Dongtan Sacred Heart Hospital

- Gangnam Severance Hospital

- Hallym University Sacred Heart Hospital

- Hanyang University Medical Center

- Incheon St. Mary's Hospital

- Kangbuk Samsung Hospital

- Keimyung University School of Medicine

- Kyung Hee University Hospital

- Kyungpook National University Chilgok Hospital

- Samsung Medical Center

- Seoul National University Hospital

- Severance hospital

**Description:** 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.

**Name:** Breast-conserving surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Recurrence in breast or chest wall and/or regional lymph nodes

**Measure:** Locoregional recurrence-free survival

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

**Description:** Recurrence in a distant organ

**Measure:** Distant recurrence-free survival

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

**Description:** Any form of disease recurrence

**Measure:** Recurrence-free survival

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

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The ON-BRCAII is multi-institution cohort study being conducted by the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Patients with primary breast cancer who underwent BCS or mastectomy and received a BRCA1/2 mutation test between January 2008 and December 2015 were retrospectively identified from 13 institutions in South Korea. The inclusion criteria comprised patients aged 20 to 80 years with invasive breast cancer (pT1-3, N0-3). The exclusion criteria consisted of patients with de novo metastasis and those with pregnancy-associated breast cancer.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Hanyang university hospital

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
