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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:
Participants will be assessed by multi-dimensional methods during and after radiation therapy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional failure rate | The event for locoregional failure rate was defined as recurrence in breast / chest wall or regional lymph node area. | 5 years from the initiation of the salvage therapy |
| Cancer-specific survival |
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Inclusion Criteria:
Exclusion Criteria:
- Not anticipated for complying the study protocol
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haeyoung Kim, MD, PhD | Contact | 82-2-3410-2612 | haeyoung0131.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Haeyoung Kim | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D016879 | Salvage Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Residual tissue archived at the pathology department after histologic confirmation of diagnosis
The event for cancer-specific survival was defined as death of the participant related to the breast cancer.
| 5 years from the initiation of the salvage therapy |
| Quality of life (BREAST-Q) | Quality of life of the participants will be evaluated according to the BREAST-Q™ questionnaires. Higher Q-Score indicates better quality of life. | 5 years from the initiation of the salvage therapy |
| Breast cosmesis | 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. | 5 years from the initiation of the salvage therapy |
| D017437 |
| Skin and Connective Tissue Diseases |