The Postoperative Radiotherapy after Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: A Prospective, Multicenter, Phase III Clinical Trial (PORT-N1)
- Conditions
- Neoplasms
- Registration Number
- KCT0007504
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 1106
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 HER-2 positive.
-Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2.
-Patients who agreed to participate in the study.
-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
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease-Free Survival
- Secondary Outcome Measures
Name Time Method ocoregional-Recurrence Free Survival;Distant-Free Survival;Overall Survival