Postoperative radiotherapy options for breast cancer patients
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
This study is testing different types of radiation therapy after breast cancer surgery to see which helps patients live longer without their cancer coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1106 (estimated) |
| Ages | 19 Years and up |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seoul, Jongro-gu) |
| Trial ID | NCT05440149 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized phase 3 clinical trial investigates the effectiveness of postoperative radiotherapy in patients with breast cancer. Participants will be randomly assigned to either receive postmastectomy radiation therapy (PMRT) or whole breast irradiation plus regional radiotherapy (WBI+regional RT), or to a group that does not receive these treatments. The study aims to determine if there is no significant difference in the 7-year disease-free survival rate between the two groups, stratifying by type of surgery and histologic type. The trial includes patients aged 19 and older who have undergone surgery for invasive breast cancer and have specific nodal involvement.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 19 or older who have undergone breast-conserving surgery or mastectomy for invasive breast cancer with stage pN1 nodal involvement.
Not a fit: Patients who have received prior neoadjuvant chemotherapy or those with stage T4 breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine optimal radiotherapy approaches, potentially reducing unnecessary treatments for certain breast cancer patients.
How similar studies have performed: Other studies have explored postoperative radiotherapy in breast cancer, but this specific approach is novel in its focus on non-inferiority regarding disease-free survival rates.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul, Jongro-gu
- Seoul National University Hospital — Seoul, Jongro-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Kyung Hwan Shin, MD. PhD. — Seoul National University Hospital
- Study coordinator: Kyung Hwan Shin, MD. PhD.
- Email: radiat@snu.ac.kr
- Phone: +82-2-2072-2524
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.