The Postoperative Radiotherapy in N1 Breast Cancer Patients
Recruiting · NCT05440149 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
No PMRT for mastectomy / No regional RT for BCSPMRT for mastectomy / WBI + Regional RT for BCS
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.
Who can take part
Age range
19 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Seoul National University Hospital - Seoul, Jongro-gu, South Korea