The Postoperative Radiotherapy in N1 Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No PMRT for mastectomy / No regional RT for BCS, PMRT for mastectomy / WBI + Regional RT for BCS.
- Who it may be relevant to
- Registry conditions: Radiotherapy, Breast Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
Overview
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.
Detailed description
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
Interventions
- Radiation 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. - Radiation 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.
Primary outcome measures
- Disease-Free Survival [Time frame: 7-Year]
Secondary outcome measures (3)
- Locoregional-Recurrence Free Survival [Time frame: 7-Year]
- Distant Metastases Free Survival [Time frame: 7-Year]
- Overall Survival [Time frame: 7-Year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Publications
- 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 36384573
Identifiers
NCT: NCT05440149 · 0720222005