NCT05933733

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
87mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress29%
Jul 2023Jul 2033

First Submitted

Initial submission to the registry

June 27, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2033

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

June 27, 2023

Last Update Submit

June 27, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival

    The event for progression-free survival was defined as any disease progression or breast cancer-related death.

    5 years from the initiation of the salvage therapy

  • Rate of adverse events

    Adverse events related to the salvage therapy will be reported and incidence rate will be calculated.

    5 years from the initiation of the salvage therapy

Secondary Outcomes (4)

  • Locoregional failure rate

    5 years from the initiation of the salvage therapy

  • Cancer-specific survival

    5 years from the initiation of the salvage therapy

  • Quality of life (BREAST-Q)

    5 years from the initiation of the salvage therapy

  • Breast cosmesis

    5 years from the initiation of the salvage therapy

Study Arms (1)

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.

Other: Salvage treatment (surgery and/or radiation therapy)

Interventions

Salvage treatment (surgery and/or radiation therapy)OTHER

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

Salvage treatment after locoregional recurrence

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Breast cancer patients who underwent standard treatment for initial breast cancer and experienced locoregional recurrence without distant metastasis which is eligible for salvage treatment can be enrolled for this study.

You may qualify if:

  • 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

You may not qualify if:

  • \- Not anticipated for complying the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Residual tissue archived at the pathology department after histologic confirmation of diagnosis

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Haeyoung Kim

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haeyoung Kim, MD, PhD

CONTACT

82-2-3410-2612haeyoung0131.kim@samsung.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

July 4, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2033

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

KR(1)