SALT-LRR: Oncologic Outcomes and Toxicities of Salvage Treatment in Patients With Locoregionally Recurrent Breast Cancer
Study Details
Study Description
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:
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Clinical outcomes after salvage treatment for locoregional recurrence
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Adverse events and quality of life after salvage treatment for locoregional recurrence
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Patient characteristics and treatment specifics which are related to the clinical outcomes and/or adverse events
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Molecular signature associated with treatment resistance
Participants will be assessed by multi-dimensional methods during and after radiation therapy:
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Assessment for the disease status (disease-free or recurrence) including physical and radiologic examination
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Assessment for the adverse events according to CTCAE version 5.0
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Assessment for the molecular signature using residual tissue after pathologic diagnosis
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Assessment for the quality of life using questionnaires (BREAST-Q)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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)
Appropriate salvage treatment (surgery and/or radiation therapy) will be selected by the treating clinicians considering the disease status.
|
Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- Locoregional failure rate [5 years from the initiation of the salvage therapy]
The event for locoregional failure rate was defined as recurrence in breast / chest wall or regional lymph node area.
- Cancer-specific survival [5 years from the initiation of the salvage therapy]
The event for cancer-specific survival was defined as death of the participant related to the breast cancer.
- Quality of life (BREAST-Q) [5 years from the initiation of the salvage therapy]
Quality of life of the participants will be evaluated according to the BREAST-Q™ questionnaires. Higher Q-Score indicates better quality of life.
- Breast cosmesis [5 years from the initiation of the salvage therapy]
Cosmesis of the breast will be evaluated according to Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/Radiation Therapy Oncology Group (RTOG) Breast Cosmesis grading scale. This is a 4-point scale (Excellent, Good, Fair, and Poor), and evaluated by the clinicians.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female patients with age 18 to 100.
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Previous standard definitive treatment for initial breast cancer
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Locoregional recurrence without distant metastasis
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Planned salvage treatment for locoregional recurrence
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Informed consent of the participant
Exclusion Criteria:
- Not anticipated for complying the study protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Haeyoung Kim, Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-05-023