Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
- Conditions
- Breast Cancer Stage III
- Interventions
- Radiation: Whole breast / chest wall & regional lymph node irradiationRadiation: Internal mammary or supraclavicular lymph node boost
- Registration Number
- NCT05896865
- Lead Sponsor
- Samsung Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 120
- 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
- Previous history of radiation therapy to the chest
- Distant metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Postoperative radiation therapy to breast / chest wall and regional lymph node area Internal mammary or supraclavicular lymph node boost 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. Postoperative radiation therapy to breast / chest wall and regional lymph node area Whole breast / chest wall & regional lymph node irradiation 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of