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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.
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:
The experimental group:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Control group | Active Comparator |
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| The Experimental group | Experimental |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No PMRT for mastectomy / No regional RT for BCS | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death. | 7-Year |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional-Recurrence Free Survival | Time from randomization to recurrence of tumors in the ipsilateral chest wall, breast or regional lymph nodes (ipsilateral axillary/internal mammary/supraclavicular lymph nodes) or breast cancer-related death. ** Recurrence should be confirmed by histological diagnosis, but local recurrence can be diagnosed by clinical examination only when regional/remote or distant metastases already exist. |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatitis | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Radiation-related pneumonitis | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale |
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.
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Hwan Shin, MD. PhD. | Contact | +82-2-2072-2524 | radiat@snu.ac.kr | |
| Bum-Sup Jang, MD. PhD. | Contact | +82-2-2072-1161 | bigwiz83@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kyung Hwan Shin, MD. PhD. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | Jongro-gu | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36384573 | Background | Lee TH, Chang JH, Jang BS, Kim JS, Kim TH, Park W, Kim YB, Kim SS, Han W, Lee HB, Shin KH. Protocol for the postoperative radiotherapy in N1 breast cancer patients (PORT-N1) trial, a prospective multicenter, randomized, controlled, non-inferiority trial of patients receiving breast-conserving surgery or mastectomy. BMC Cancer. 2022 Nov 16;22(1):1179. doi: 10.1186/s12885-022-10285-0. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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|
| PMRT for mastectomy / WBI + Regional RT for BCS | Radiation |
|
|
| 7-Year |
| Distant Metastases Free Survival | Time from randomization to the development of distant metastases or breast cancer-related death. | 7-Year |
| Overall Survival | Time from randomization to the death due to any cause. | 7-Year |
| Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Major complication rate for reconstructed breast | For patients who received breast reconstruction after mastectomy | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Occurence of contralateral in-situ or invasive breast cancer | Pathologic confirmation | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Major cardiac event | Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Ipsilateral rib fracture | Symptom or radiologic diagnosis | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| Arm Lymphedema | Symptom / Diagnosis from the related-department (e.g. rehab) / Expert opinion | Every 6 month during 1 years, then every 1 year till 7 years after randomization |
| D017437 |
| Skin and Connective Tissue Diseases |