Breast Cancer Stage III Clinical Trial
— RADAPT-N3Official title:
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial
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
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 16, 2030 |
Est. primary completion date | March 16, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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. | 5 years from the initiation of the radiation therapy | |
Secondary | Adverse events | Adverse events after radiation therapy is graded according to CTCAE version 5.0. | 5 years from the initiation of the radiation therapy | |
Secondary | 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 |
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