BRCA1/2 MutationNCT06429644
Long-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
An observational study of BRCA1/2 Mutation and Breast-conserving Surgery, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- BRCA1/2 Mutation, Breast-conserving Surgery
- What is being tested?
- Breast-conserving surgery
- Type of treatment
- Surgery or procedure
- How many people
- 4,010 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2022to 8 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- 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.
Who may be able to join
- Primary invasive breast cancer who underwent BCS or mastectomy
- Received a BRCA1/2 mutation test
Who cannot join
- Patients with de novo metastasis
- Pregnancy-associated breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
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.
Read the 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
- BRCA1/2 Mutation, Breast-conserving Surgery
- Being tested
- Breast-conserving surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast-conserving surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Dongtan Sacred Heart Hospital | Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University, Dongtan, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Samsung Medical Center | Division of Breast Surgery, Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Seoul National University Hospital | Breast Care Center, Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Severance hospital | Department of Surgery, Severance hospital, Yonsei University College of Medicine, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Kyungpook National University Chilgok Hospital | Department of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Gangnam Severance Hospital | Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Hanyang University Medical Center | Department of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Hallym University Sacred Heart Hospital | Department of Breast \& Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Kangbuk Samsung Hospital | Department of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| 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 Receives: Procedure: Breast-conserving surgery | |
| Kyung Hee University Hospital | Department of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Keimyung University School of Medicine | Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea Receives: Procedure: Breast-conserving surgery | |
| Asan Medical Center | Division of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea Receives: Procedure: Breast-conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence-free survival
Recurrence in breast or chest wall and/or regional lymph nodes
Measured: Duration from diagnosis until the development of recurrence up to 10year
Distant recurrence-free survival
Recurrence in a distant organ
Measured: Duration from diagnosis until the development of recurrence up to 10year
Recurrence-free survival
Any form of disease recurrence
Measured: Duration from diagnosis until the development of recurrence up to 10year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start7 Jul 2022
- Primary completion31 Dec 2023
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA1/2 MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korean Surgical Society, Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429644
- Sponsor's protocol ID
- 2022-04-039
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ong-term Oncologic Outcome of Breast-conserving Surgery in Breast Cancer Patients With BRCA1/2 Mutations
- ClinicalTrials.gov ID
- NCT06429644
- Acronym / sponsor ID
- 2022-04-039
- Conditions
- BRCA1/2 Mutation, Breast-conserving Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,010 participants (actual)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Korean Surgical Society, Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Dongtan Sacred Heart Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Dongtan Sacred Heart Hospital, Hallym University, Dongtan, Republic of Korea |
| Samsung Medical Center | – | Procedure: Breast-conserving surgeryDivision of Breast Surgery, Department of Surgery, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea |
| Seoul National University Hospital | – | Procedure: Breast-conserving surgeryBreast Care Center, Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea |
| Severance hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Severance hospital, Yonsei University College of Medicine, Seoul, Republic of Korea |
| Kyungpook National University Chilgok Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, School of Medicine, Kyungpook National University, Kyungpook National University Chilgok Hospital, Daegu, Republic of Korea |
| Gangnam Severance Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea |
| Hanyang University Medical Center | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Hanyang University Medical Center, Hanyang University College of Medicine, Seoul, Republic of Korea |
| Hallym University Sacred Heart Hospital | – | Procedure: Breast-conserving surgeryDepartment of Breast \& Endocrine Surgery, Hallym University Sacred Heart Hospital, Hallym University, Anyang, Republic of Korea |
| Kangbuk Samsung Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea |
| Incheon St. Mary's Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Incheon, Republic of Korea |
| Kyung Hee University Hospital | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea |
| Keimyung University School of Medicine | – | Procedure: Breast-conserving surgeryDepartment of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea |
| Asan Medical Center | – | Procedure: Breast-conserving surgeryDivision of Breast Surgery, Department of Surgery, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Primary invasive breast cancer who underwent BCS or mastectomy
- Received a BRCA1/2 mutation test
Key exclusion criteria (2 listed)
- Patients with de novo metastasis
- Pregnancy-associated breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast-conserving surgeryBreast-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. | Procedure or surgery | 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 |
Primary outcome
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
Distant recurrence-free survival
Time frame: Duration from diagnosis until the development of recurrence up to 10year
Recurrence in a distant organ
Recurrence-free survival
Time frame: Duration from diagnosis until the development of recurrence up to 10year
Any form of disease recurrence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRCA1/2 Mutation and Breast-conserving Surgery, run by Hanyang University Seoul Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional recurrence-free survival (time frame: Duration from diagnosis until the development of recurrence up to 10year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.