Seoul National University Hospital
Seoul, Jongro-gu, 03080, South Korea
Location status: Recruiting
NCT Number: NCT05440149
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.
Interested in participating?
Request Info19 year and older
Female
Interventional
Phase 3
Seoul, Jongro-gu, 03080, South Korea
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 7-Year
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
Time frame: 7-Year
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.
Time frame: 7-Year
Time from randomization to the development of distant metastases or breast cancer-related death.
Time frame: 7-Year
Time from randomization to the death due to any cause.
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
For patients who received breast reconstruction after mastectomy
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Pathologic confirmation
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Symptom or radiologic diagnosis
Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Symptom / Diagnosis from the related-department (e.g. rehab) / Expert opinion
Contact information is provided by the study sponsor or research team.
Bum-Sup Jang, MD. PhD.
CONTACT
Kyung Hwan Shin, MD. PhD.
CONTACT
Seoul National University Hospital
Other
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
Acronym: PORT-N1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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