Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Salvage treatment (surgery and/or radiation therapy).
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
Overview
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)
Interventions
- Other 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.
Primary outcome measures
- Progression-free survival [Time frame: 5 years from the initiation of the salvage therapy]
- Rate of adverse events [Time frame: 5 years from the initiation of the salvage therapy]
Secondary outcome measures (4)
- Locoregional failure rate [Time frame: 5 years from the initiation of the salvage therapy]
- Cancer-specific survival [Time frame: 5 years from the initiation of the salvage therapy]
- Quality of life (BREAST-Q) [Time frame: 5 years from the initiation of the salvage therapy]
- Breast cosmesis [Time frame: 5 years from the initiation of the salvage therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT05933733 · 2023-05-023