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Completed

NCT Number: NCT06429644

Long-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.

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Key information

Conditions

BRCA1/2 Mutation Breast-conserving Surgery

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Hanyang university hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast-conserving surgery

Procedure

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.

Primary outcomes

  1. 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

  2. Distant recurrence-free survival

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

    Recurrence in a distant organ

  3. Recurrence-free survival

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

    Any form of disease recurrence

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Collaborators

  • Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group
  • Korean Surgical Society

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 28, 2024
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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