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

NCT05896865 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-06-29

No results posted yet for this 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

Conditions

  • Breast Cancer Stage III

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Haeyoung Kim, MD, PhD · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2028-03-16
Completion
2030-03-16

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896865 on ClinicalTrials.gov