Breast Cancer, Radiotherapy
Conditions
Keywords
Breast Cancer, Radiotherapy, Omission, Breast Conserving Surgery, Mastectomy, TNM pathologic stage N1
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.
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
RADIATIONNo 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.
RADIATIONPMRT 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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-Free Survival | 7-Year | Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 7-Year | Time from randomization to the death due to any cause. |
| Locoregional-Recurrence Free Survival | 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. |
| Distant Metastases Free Survival | 7-Year | Time from randomization to the development of distant metastases or breast cancer-related death. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurence of contralateral in-situ or invasive breast cancer | Every 6 month during 1 years, then every 1 year till 7 years after randomization | Pathologic confirmation |
| Major cardiac event | Every 6 month during 1 years, then every 1 year till 7 years after randomization | Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death |
| Ipsilateral rib fracture | Every 6 month during 1 years, then every 1 year till 7 years after randomization | Symptom or radiologic diagnosis |
| Arm Lymphedema | 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 |
| Dermatitis | 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 |
| Radiation-related pneumonitis | 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 |
| Major complication rate for reconstructed breast | Every 6 month during 1 years, then every 1 year till 7 years after randomization | For patients who received breast reconstruction after mastectomy |
Countries
South Korea
Contacts
Primary ContactKyung Hwan Shin, MD. PhD.
Backup ContactBum-Sup Jang, MD. PhD.
Outcome results
None listed