NCT05896865 Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer
| NCT ID | NCT05896865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Breast Cancer Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-16 |
| Primary Completion | 2028-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-03-16 with a primary completion date of 2028-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Haeyoung Kim, MD, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT05896865 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Breast Cancer Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896865 currently recruiting?
Yes, NCT05896865 is actively recruiting participants. Contact the research team at haeyoung0131.kim@samsung.com for enrollment information.
Where is the NCT05896865 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05896865 clinical trial?
NCT05896865 is sponsored by Samsung Medical Center. The principal investigator is Haeyoung Kim, MD, PhD at Samsung Medical Center. The trial plans to enroll 120 participants.
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