Radiotherapy Dose Adaptation Based on Tumor Biology in Patients With cN2b-N3 Breast Cancer: Non-randomized Phase II, Prospective Single Arm Study Clinical Trial

Samsung Medical Center1 site in 1 country120 target enrollmentMarch 16, 2023

ConditionsBreast Cancer Stage III

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer Stage III
Sponsor: Samsung Medical Center
Enrollment: 120
Locations: 1
Primary Endpoint: 5-year disease-free survival
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 16, 2023

End Date

March 16, 2030

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Haeyoung Kim

Associate professor

Samsung Medical Center

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

Outcomes

Primary Outcomes

5-year disease-free survival

Time Frame: 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 Outcomes

Quality of life (BREAST-Q™)(5 years from the initiation of the radiation therapy)
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)