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

Not Applicable

Recruiting

• Conditions: Breast Cancer Stage III

• Registration Number: NCT05896865
• Lead Sponsor: Samsung Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-16
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Study First Posted: 2023-06-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-06-29
• Primary Completion: 2028-03-16
• Study Completion: 2030-03-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Quality of life (BREAST-Q™)	5 years from the initiation of the radiation therapy	Quality of life is assessed by BREAST-Q™ questionnaires. Each score from BREAST-Q™ scales ranges from 0 to 100. Higher scores reflect a better outcome except Cancer Worry scale.
5-year overall survival	5 years from the initiation of the radiation therapy	The event for overall survival is defined as death of patient with any cause.
5-year locoregional recurrence	5 years from the initiation of the radiation therapy	The event for locoregional recurrence is defined as disease recurrence in irradiated breast / chest wall and/or regional lymph node area including internal mammary and supraclavicular lymph node area.
Adverse events	5 years from the initiation of the radiation therapy	Adverse events after radiation therapy is graded according to CTCAE version 5.0.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of