ClinicalTrials.gg
CompletedNCT06429644Updated May 28, 2024

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

An observational study in BRCA1/2 Mutation and Breast-conserving Surgery, sponsored by Hanyang University Seoul Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Hanyang University Seoul Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,010
Ages
20 Years to 80 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • BRCA1/2 Mutation
  • Breast-conserving Surgery
03

In context

Lead sponsor

Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary invasive breast cancer who underwent BCS or mastectomy
  • Received a BRCA1/2 mutation test

Exclusion criteria

Exclusion Criteria:

  • Patients with de novo
  • Pregnancy-associated breast cancer
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,010 participants (actual)
Patient registry
No

Groups and cohorts

  • Dongtan Sacred Heart Hospital

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

    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

    Procedure: Breast-conserving surgery

  • Seoul National University Hospital

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

    Procedure: Breast-conserving surgery

  • Severance hospital

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

    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

    Procedure: Breast-conserving surgery

  • Gangnam Severance Hospital

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

    Procedure: Breast-conserving surgery

  • Hanyang University Medical Center

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

    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

    Procedure: Breast-conserving surgery

  • Kangbuk Samsung Hospital

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

    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

    Procedure: Breast-conserving surgery

  • Kyung Hee University Hospital

    Department of Surgery, Kyung Hee University Hospital, Seoul, Republic of Korea

    Procedure: Breast-conserving surgery

  • Keimyung University School of Medicine

    Department of Surgery, Keimyung University School of Medicine, Daegu, Republic of Korea

    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

    Procedure: Breast-conserving surgery

Interventions

  • ProcedureBreast-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.

06

What researchers measure

Primary outcomes

  1. Locoregional recurrence-free survival

    Recurrence in breast or chest wall and/or regional lymph nodes

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

  2. Distant recurrence-free survival

    Recurrence in a distant organ

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

  3. Recurrence-free survival

    Any form of disease recurrence

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

07

Study locations

1 site
  • Hanyang university hospital
    Seoul, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2022 to primary completion in Dec 2023, 17 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2024
First posted
May 28, 2024
StartActual
Jul 7, 2022
Primary completionActual
Dec 31, 2023
CompletionActual
Apr 8, 2024
Last update
May 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06429644
Lead sponsor
Hanyang University Seoul Hospital
Collaborators
Korean Surgical Society, Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
Responsible party
Sponsor
First posted
May 28, 2024
Start date
Jul 7, 2022
Primary completion
Dec 31, 2023
Completion
Apr 8, 2024
Last update
May 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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