RecruitingRecruiting
The Postoperative Radiotherapy in N1 Breast Cancer Patients
NCT05440149 · Seoul National University Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
About this study
1:1 randomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery (BCS) versus mastectomy) and the type of histologic type (triple negative breast cancer (TNBC) versus non-TNBC)
The control group:
* If patients received BCS, WBI+Regional RT
* If patients received mastectomy, PMRT
The experimental group:
* If patients received breast conserving surgery, WBI alone
* If patients received mastectomy, No PMRT
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.
Study design
Enrollment target: 1106 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-08-01
Estimated completion: 2033-12-31
Last updated: 2024-11-29
Interventions
Radiation: No PMRT for mastectomy / No regional RT for BCSRadiation: PMRT for mastectomy / WBI + Regional RT for BCS
Primary outcomes
- • Disease-Free Survival (7-Year)
Sponsor
Seoul National University Hospital · other
Contacts & investigators
ContactKyung Hwan Shin, MD. PhD. · contact · radiat@snu.ac.kr · +82-2-2072-2524
ContactBum-Sup Jang, MD. PhD. · contact · bigwiz83@snu.ac.kr · +82-2-2072-1161
InvestigatorKyung Hwan Shin, MD. PhD. · principal_investigator, Seoul National University Hospital
All locations (1)
Seoul National University HospitalRecruiting
Seoul, Jongro-gu, South Korea