Breast Cancer Stage III
Conditions
Brief summary
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: * 5-year disease-free survival * 5-year overall survival * 5-year locoregional recurrence * Adverse events after radiation therapy * Quality of life Participants will be assessed by multi-dimensional methods before and after radiotherapy: * Disease status evaluation including physical and radiological examination * Quality of life assessment with questionnaires (BREAST-Q) * Adverse event assessment according to CTCAE version 5.0
Interventions
RADIATIONInternal mammary or supraclavicular lymph node boost
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
RADIATIONWhole breast / chest wall & regional lymph node irradiation
Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female with age 19 or older * Metastasis to internal mammary and/or supraclavicular lymph nodes, assessed by radiological exams and/or biopsy * Underwent neoadjuvant chemotherapy * Pathologic confirmation of invasive breast cancer treated with breast conserving surgery or mastectomy * Eastern Cooperative Oncology Group performance status 0-2 * Informed consent
Exclusion criteria
* Previous history of radiation therapy to the chest * Distant metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year disease-free survival | 5 years from the initiation of the radiation therapy | The event for disease-free survival is defined as any disease recurrence or breast cancer-related death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 years from the initiation of the radiation therapy | The event for overall survival is defined as death of patient with any cause. |
| 5-year locoregional recurrence | 5 years from the initiation of the radiation therapy | 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. |
| Adverse events | 5 years from the initiation of the radiation therapy | Adverse events after radiation therapy is graded according to CTCAE version 5.0. |
| Quality of life (BREAST-Q™) | 5 years from the initiation of the radiation therapy | 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. |
Countries
South Korea
Contacts
Primary ContactHaeyoung Kim, MD, PhD
Outcome results
None listed