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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - willing to sign a consent form Who Should NOT Join This Trial: - Previous history of radiation therapy to the chest - Distant metastasis Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

RADIATION

Whole breast / chest wall & regional lymph node irradiation

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

RADIATION

Internal mammary or supraclavicular lymph node boost

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

Locations (1)

Samsung Medical Center
Seoul, South Korea