Status:
RECRUITING
The Postoperative Radiotherapy in N1 Breast Cancer Patients
Lead Sponsor:
Seoul National University Hospital
Conditions:
Radiotherapy
Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE3
Brief Summary
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 re...
Detailed Description
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative br...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2033
Estimated Enrollment :
1106 Patients enrolled
Trial Details
Trial ID
NCT05440149
Start Date
August 1 2022
End Date
December 31 2033
Last Update
November 29 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, Jongro-gu, South Korea, 03080