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Recruiting Observational

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

NCT05933733 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2023-07-04
Last updated
2025-06-29

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Salvage treatment (surgery and/or radiation therapy)

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.

Study summary

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)

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Progression-free survival — 5 years from the initiation of the salvage therapy
    The event for progression-free survival was defined as any disease progression or breast cancer-related death.
  • Rate of adverse events — 5 years from the initiation of the salvage therapy
    Adverse events related to the salvage therapy will be reported and incidence rate will be calculated.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05933733 on ClinicalTrials.gov ↗ ← All trials in South Korea