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Clinical Trials in South Korea / NCT05896865
Recruiting Not applicable

Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer

NCT05896865 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Not applicable
Started
2023-03-16
Last updated
2025-06-29

Condition(s) studied

Breast Cancer Stage III

Investigational drug(s) / intervention(s)

Whole breast / chest wall & regional lymph node irradiationInternal mammary or supraclavicular lymph node boost

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

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

Study 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

Sex
FEMALE
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05896865 on ClinicalTrials.gov ↗ ← All trials in South Korea