The Postoperative Radiotherapy in N1 Breast Cancer Patients

Recruiting now · Phase 3

Conditions studied: Radiotherapy, Breast Cancer

In brief

This study is a multicenter, randomized, phase 3 clinical trial in patients with breast cancer, randomizing radiotherapy group (postmastectomy radiation therapy (PMRT)/whole breast irradiation plus regional radiotherapy (WBI+regional RT) versus and no PMRT/WBI alone group. This is a non-inferiority study aiming that there is no significant difference in the 7-year disease-free survival rate between the two groups.

Key facts

Study ID

NCT05440149

Run by

Seoul National University Hospital

People needed

1106

Starts

2022-08-01

Expected to finish

2033-12-31

Last updated by the study team

2024-11-29

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 19 years or older.
• A female patient who underwent breast-conserving surgery or mastectomy for invasive breast cancer.
• Patient with stage pN1 after surgery on histopathologic examination.
• However, if mastectomy was performed, 5 or more nodes should be resected in the case of 1 positive node, and axillary lymph node dissection (ALND) should be performed in case of 2 or 3 positive nodes.
• Patients undergoing or planning to undergo hormone therapy in the case of hormone receptor positive.
• Patients who have received or are expected to undergo targeted therapy in the case of human epidermal growth factor receptor(HER)-2 positive.
• Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
• Patients who agreed to participate in the study.

You may not qualify if…

• Patients who have received prior [neoadjuvant] chemotherapy.
• Patients receiving radiation therapy for salvage or palliative purposes.
• Patients with stage T4.
• Patients with ipsilateral supraclavicular and internal mammary lymph node metastases or distant metastases.
• Male breast cancer patient.
• Patients who have previously received radiation therapy to the ipsilateral breast or supraclavicular region.
• Patients having a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
• Patients diagnosed with ductal breast carcinoma in situ, lobular carcinoma in situ, phyllodes, metaplastic cancer, or benign tumors based on histological diagnosis.

Where it is running

• Seoul National University Hospital — Seoul, Jongro-gu, South Korea (enrolling)

Full record on ClinicalTrials.gov

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