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Trial Title:
Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
NCT ID:
NCT05896865
Condition:
Breast Cancer Stage III
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Whole breast / chest wall & regional lymph node irradiation
Description:
Whole breast / chest wall and corresponding regional lymph node irradiation with dose of
42.4 Gy in 16 fractions
Arm group label:
Postoperative radiation therapy to breast / chest wall and regional lymph node area
Intervention type:
Radiation
Intervention name:
Internal mammary or supraclavicular lymph node boost
Description:
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
Arm group label:
Postoperative radiation therapy to breast / chest wall and regional lymph node area
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
Criteria for 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Haeyoung Kim, MD, PhD
Phone:
82-2-3410-2612
Email:
haeyoung0131.kim@samsung.com
Start date:
March 16, 2023
Completion date:
March 16, 2030
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05896865
