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The Postoperative Radiotherapy in N1 Breast Cancer Patients

NCT05440149 · Seoul National University Hospital
In plain English

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Official title
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
About this study
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 breast cancer (TNBC) versus non-TNBC) The control group: * If patients received BCS, WBI+Regional RT * If patients received mastectomy, PMRT The experimental group: * If patients received breast conserving surgery, WBI alone * If patients received mastectomy, No PMRT
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Study design
Enrollment target: 1106 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-08-01
Estimated completion: 2033-12-31
Last updated: 2024-11-29
Interventions
Radiation: No PMRT for mastectomy / No regional RT for BCSRadiation: PMRT for mastectomy / WBI + Regional RT for BCS
Primary outcomes
  • Disease-Free Survival (7-Year)
Sponsor
Seoul National University Hospital · other
Contacts & investigators
ContactKyung Hwan Shin, MD. PhD. · contact · radiat@snu.ac.kr · +82-2-2072-2524
ContactBum-Sup Jang, MD. PhD. · contact · bigwiz83@snu.ac.kr · +82-2-2072-1161
InvestigatorKyung Hwan Shin, MD. PhD. · principal_investigator, Seoul National University Hospital
All locations (1)
Seoul National University HospitalRecruiting
Seoul, Jongro-gu, South Korea
The Postoperative Radiotherapy in N1 Breast Cancer Patients · TrialPath