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The purpose of the study is to evaluate treatment outcomes of breast cancer with internal mammary or supraclavicular lymph node metastasis according to total radiation dose of postoperative radiation therapy differentiated by tumor response to neoadjuvant chemotherapy.
The main questions it aims to answer are:
Participants will be assessed by multi-dimensional methods before and after radiotherapy:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative radiation therapy to breast / chest wall and regional lymph node area | Experimental | Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions. Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole breast / chest wall & regional lymph node irradiation | Radiation | Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year disease-free survival | The event for disease-free survival is defined as any disease recurrence or breast cancer-related death | 5 years from the initiation of the radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year overall survival | The event for overall survival is defined as death of patient with any cause. | 5 years from the initiation of the radiation therapy |
| 5-year locoregional recurrence | The event for locoregional recurrence is defined as disease recurrence in irradiated breast / chest wall and/or regional lymph node area including internal mammary and supraclavicular lymph node area. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haeyoung Kim, MD, PhD | Contact | 82-2-3410-2612 | haeyoung0131.kim@samsung.com |
| Name | Affiliation | Role |
|---|---|---|
| Haeyoung Kim, MD, PhD | 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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| Internal mammary or supraclavicular lymph node boost | Radiation | Simultaneous boost to Internal mammary or supraclavicular lymph node area with dose of total 53.6 Gy or 56.0 Gy in 16 fractions, depending on the response after neoadjuvant chemotherapy |
|
| 5 years from the initiation of the radiation therapy |
| Adverse events | Adverse events after radiation therapy is graded according to CTCAE version 5.0. | 5 years from the initiation of the radiation therapy |
| Quality of life (BREAST-Q™) | Quality of life is assessed by BREAST-Q™ questionnaires. Each score from BREAST-Q™ scales ranges from 0 to 100. Higher scores reflect a better outcome except Cancer Worry scale. | 5 years from the initiation of the radiation therapy |
| D017437 |
| Skin and Connective Tissue Diseases |