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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Haeyoung Kim, MD, PhD
haeyoung0131.kim@samsung.com
82-2-3410-2612
Time Frame
Start Date: 2023-03-16
Estimated Completion Date: 2030-03-16
Participants
Target number of participants: 120
Treatments
Experimental: Postoperative radiation therapy to breast / chest wall and regional lymph node area
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.
Related Therapeutic Areas
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov