NCT05933733
Recruiting
N/A
A Prospective Registry Study to Evaluate Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
ConditionsBreast Cancer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Samsung Medical Center
- Enrollment
- 190
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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)
Investigators
Haeyoung Kim
Associate Professor
Samsung Medical Center
Eligibility Criteria
Inclusion Criteria
- •Female patients with age 18 to
- •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
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Cancer-specific survival(5 years from the initiation of the salvage therapy)
- Breast cosmesis(5 years from the initiation of the salvage therapy)
- Locoregional failure rate(5 years from the initiation of the salvage therapy)
- Quality of life (BREAST-Q)(5 years from the initiation of the salvage therapy)
Study Sites (1)
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