Actively Recruiting
The Postoperative Radiotherapy in N1 Breast Cancer Patients
Led by Seoul National University Hospital · Updated on 2024-11-29
1106
Participants Needed
1
Research Sites
595 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Postoperative Radiotherapy in N1 Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older.
- Female patients who had breast-conserving surgery or mastectomy for invasive breast cancer.
- Patients with stage pN1 disease confirmed after surgery.
- For mastectomy patients with 1 positive node, at least 5 nodes must have been removed.
- For mastectomy patients with 2 or 3 positive nodes, axillary lymph node dissection must have been performed.
- Patients undergoing or planning hormone therapy if hormone receptor positive.
- Patients who have received or plan to receive targeted therapy if HER-2 positive.
- Patients with an Eastern Cooperative Oncology Group performance status of 0 to 2.
- Patients who have agreed to participate in the study.
You will not qualify if you...
- Patients who have received prior neoadjuvant chemotherapy.
- Patients receiving radiation therapy for salvage or palliative purposes.
- Patients with stage T4 cancer.
- Patients with metastases in ipsilateral supraclavicular or internal mammary lymph nodes or distant metastases.
- Male breast cancer patients.
- Patients who previously received radiation to the ipsilateral breast or supraclavicular region.
- Patients with a history of cancer other than thyroid cancer, cervical carcinoma in situ, or skin cancer.
- Patients diagnosed with ductal carcinoma in situ, lobular carcinoma in situ, phyllodes tumor, metaplastic cancer, or benign tumors based on histology.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongro-gu, South Korea, 03080
Actively Recruiting
Research Team
K
Kyung Hwan Shin, MD. PhD.
CONTACT
B
Bum-Sup Jang, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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