About this 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous history of radiation therapy to the chest
Distant metastasis
Trial design
Single group
Treatments tested in this trial
Whole breast / chest wall & regional lymph node irradiation
RadiationWhole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions
Internal mammary or supraclavicular lymph node boost
RadiationSimultaneous 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
Treatment groups
Trial outcomes
Primary outcomes
5-year disease-free survival
The event for disease-free survival is defined as any disease recurrence or breast cancer-related death
Secondary outcomes
5-year overall survival
The event for overall survival is defined as death of patient with any cause.
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.
Adverse events
Adverse events after radiation therapy is graded according to CTCAE version 5.0.
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.
Sponsors and contacts
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