NCT05896865

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
44mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Mar 2023Mar 2030

Study Start

First participant enrolled

March 16, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2030

Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

May 31, 2023

Last Update Submit

June 27, 2025

Conditions

Breast Cancer Stage III

Outcome Measures

Primary Outcomes (1)

  • 5-year disease-free survival

    The event for disease-free survival is defined as any disease recurrence or breast cancer-related death

    5 years from the initiation of the radiation therapy

Secondary Outcomes (4)

  • 5-year overall survival

    5 years from the initiation of the radiation therapy

  • 5-year locoregional recurrence

    5 years from the initiation of the radiation therapy

  • Adverse events

    5 years from the initiation of the radiation therapy

  • Quality of life (BREAST-Q™)

    5 years from the initiation of the radiation therapy

Study Arms (1)

Postoperative radiation therapy to breast / chest wall and regional lymph node area

EXPERIMENTAL

Patient achieved complete response after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 53.6 Gy in 16 fractions. Patient with partial response, stable disease, or progressive disease after neoadjuvant chemotherapy will receive postoperative radiation therapy with dose of 42.4 Gy in 16 fractions to whole breast / chest wall and regional lymph node area. Internal mammary or supraclavicular lymph node area boost will be simultaneously delivered with total dose of 56.0 Gy in 16 fractions.

Radiation: Whole breast / chest wall & regional lymph node irradiationRadiation: Internal mammary or supraclavicular lymph node boost

Interventions

Whole breast / chest wall & regional lymph node irradiationRADIATION

Whole breast / chest wall and corresponding regional lymph node irradiation with dose of 42.4 Gy in 16 fractions

Postoperative radiation therapy to breast / chest wall and regional lymph node area
Internal mammary or supraclavicular lymph node boostRADIATION

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

Postoperative radiation therapy to breast / chest wall and regional lymph node area

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous history of radiation therapy to the chest
  • Distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Haeyoung Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haeyoung Kim, MD, PhD

CONTACT

82-2-3410-2612haeyoung0131.kim@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

March 16, 2023

Primary Completion (Estimated)

March 16, 2028

Study Completion (Estimated)

March 16, 2030

Last Updated

June 29, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)