Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Whole breast / chest wall & regional lymph node irradiation, Internal mammary or supraclavicular lymph node boost.
- Who it may be relevant to
- Registry conditions: Breast Cancer Stage III. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Radiation Whole 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 - Radiation Internal 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
Primary outcome measures
- 5-year disease-free survival [Time frame: 5 years from the initiation of the radiation therapy]
Secondary outcome measures (4)
- 5-year overall survival [Time frame: 5 years from the initiation of the radiation therapy]
- 5-year locoregional recurrence [Time frame: 5 years from the initiation of the radiation therapy]
- Adverse events [Time frame: 5 years from the initiation of the radiation therapy]
- Quality of life (BREAST-Q™) [Time frame: 5 years from the initiation of the radiation therapy]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT05896865 · 2023-01-012