The Postoperative Radiotherapy in N1 Breast Cancer Patients
NCT ID: NCT05440149
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
1106 participants
INTERVENTIONAL
2022-08-01
2033-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The Control group
* 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.
PMRT for mastectomy / WBI + Regional RT for BCS
* 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.
The Experimental group
* If patients received mastectomy, No PMRT should be performed.
* If patients received BCS, WBI alone should be performed.
No PMRT for mastectomy / No regional RT for BCS
* 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No PMRT for mastectomy / No regional RT for BCS
* 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.
PMRT for mastectomy / WBI + Regional RT for BCS
* 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
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
19 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kyung Hwan Shin
Professor, Chairman
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kyung Hwan Shin, MD. PhD.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, Jongro-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0720222005
Identifier Type: -
Identifier Source: org_study_id