NCT05440149 The Postoperative Radiotherapy in N1 Breast Cancer Patients
| NCT ID | NCT05440149 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Seoul National University Hospital |
| Condition | Radiotherapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,106 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,106 participants in total. It began in 2022-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Kyung Hwan Shin, MD. PhD.
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05440149 clinical trial?
This trial is open to female participants only, aged 19 Years or older, studying Radiotherapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05440149 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,106 participants.
Is NCT05440149 currently recruiting?
Yes, NCT05440149 is actively recruiting participants. Contact the research team at radiat@snu.ac.kr for enrollment information.
Where is the NCT05440149 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05440149 clinical trial?
NCT05440149 is sponsored by Seoul National University Hospital. The principal investigator is Kyung Hwan Shin, MD. PhD. at Seoul National University Hospital. The trial plans to enroll 1,106 participants.