Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
1 other identifier
observational
4,010
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2024
CompletedFirst Submitted
Initial submission to the registry
April 30, 2024
CompletedFirst Posted
Study publicly available on registry
May 28, 2024
CompletedMay 28, 2024
April 1, 2024
1.5 years
April 30, 2024
May 23, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Distant recurrence-free survival
Recurrence in a distant organ
Duration from diagnosis until the development of recurrence up to 10year
Recurrence-free survival
Any form of disease recurrence
Duration from diagnosis until the development of recurrence up to 10year
Study Arms (13)
Dongtan Sacred Heart Hospital
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University, Dongtan, Republic of Korea
Samsung Medical Center
Division of Breast Surgery, Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea
Seoul National University Hospital
Breast Care Center, Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea
Severance hospital
Department of Surgery, Severance hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
Kyungpook National University Chilgok Hospital
Department of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea
Gangnam Severance Hospital
Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea
Hanyang University Medical Center
Department of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea
Hallym University Sacred Heart Hospital
Department of Breast \& Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, Republic of Korea
Kangbuk Samsung Hospital
Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
Incheon St. Mary's Hospital
Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea
Kyung Hee University Hospital
Department of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea
Keimyung University School of Medicine
Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea
Asan Medical Center
Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Primary invasive breast cancer who underwent BCS or mastectomy
- Received a BRCA1/2 mutation test
You may not qualify if:
- Patients with de novo metastasis
- Pregnancy-associated breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang university hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2024
First Posted
May 28, 2024
Study Start
July 7, 2022
Primary Completion
December 31, 2023
Study Completion
April 8, 2024
Last Updated
May 28, 2024
Record last verified: 2024-04