The Postoperative Radiotherapy in N1 Breast Cancer Patients
PORT-N1
1 other identifier
interventional
1,106
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2022
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2033
November 29, 2024
November 1, 2024
4.4 years
June 27, 2022
November 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
7-Year
Secondary Outcomes (3)
Locoregional-Recurrence Free Survival
7-Year
Distant Metastases Free Survival
7-Year
Overall Survival
7-Year
Other Outcomes (7)
Dermatitis
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Radiation-related pneumonitis
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Major complication rate for reconstructed breast
Every 6 month during 1 years, then every 1 year till 7 years after randomization
- +4 more other outcomes
Study Arms (2)
The Control group
ACTIVE COMPARATOR* If patients received mastectomy, post-mastectomy radiation therapy (PMRT) should be performed. * If patients received breast conserving surgery (BCS), whole breast irradiation (WBI) + Regional radiotherapy (RT) should be performed.
The Experimental group
EXPERIMENTAL* If patients received mastectomy, No PMRT should be performed. * If patients received BCS, WBI alone should be performed.
Interventions
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
* Regional RT includes high-tangent field, and can include undissected axilla. * The definition of high-tangent is that the upper margin of the radiotherapy field located within 2 cm of the humeral head to include axillary levels I and II. * Both hypofractionated and conventionally fractionated radiation therapy are allowed, and 3-dimensional or intensity modulated radiotherapy are allowed. The electron beam can also be used.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Jongro-gu, 03080, South Korea
Related Publications (1)
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.
PMID: 36384573BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyung Hwan Shin, MD. PhD.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chairman
Study Record Dates
First Submitted
June 27, 2022
First Posted
June 30, 2022
Study Start
August 1, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2033
Last Updated
November 29, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share