Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer

NCT ID: NCT05933733

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2033-07-31

Brief Summary

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The purpose of this study is to evaluate clinical outcomes and adverse events of salvage treatment for locoregional recurrence of breast cancer.

The main questions it aims to answer are:

* Clinical outcomes after salvage treatment for locoregional recurrence
* Adverse events and quality of life after salvage treatment for locoregional recurrence
* Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
* Molecular signature associated with treatment resistance

Participants will be assessed by multi-dimensional methods during and after radiation therapy:

* Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
* Assessment for the adverse events according to CTCAE version 5.0
* Assessment for the molecular signature using residual tissue after pathologic diagnosis
* Assessment for the quality of life using questionnaires (BREAST-Q)

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Salvage treatment after locoregional recurrence

Participants who previously completed standard treatment for breast cancer and experienced locoregional recurrence alone will be undergo salvage treatment including surgery and/or radiation therapy.

Salvage treatment (surgery and/or radiation therapy)

Intervention Type OTHER

Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the treating clinicians considering the disease status.

Interventions

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Salvage treatment (surgery and/or radiation therapy)

Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the treating clinicians considering the disease status.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female patients with age 18 to 100.
* Previous standard definitive treatment for initial breast cancer
* Locoregional recurrence without distant metastasis
* Planned salvage treatment for locoregional recurrence
* Informed consent of the participant

Exclusion Criteria

\- Not anticipated for complying the study protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Haeyoung Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haeyoung Kim

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Haeyoung Kim, MD, PhD

Role: CONTACT

82-2-3410-2612

Facility Contacts

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Haeyoung Kim, MD, PhD

Role: primary

82-2-3410-2612

Other Identifiers

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2023-05-023

Identifier Type: -

Identifier Source: org_study_id

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