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

Samsung Medical Center

Status: Enrolling

Conditions: Breast Cancer Stage III

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05896865

2023-01-012

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Radiation: Whole breast / chest wall & regional lymph node irradiation

Radiation: Internal mammary or supraclavicular lymph node boost