Clinical trial NCT05440149: The Postoperative Radiotherapy in N1 Breast Cancer Patients
Official title: The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Radiotherapy
Breast Cancer
Keywords: Breast Cancer
Radiotherapy
Omission
Breast Conserving Surgery
Mastectomy
TNM pathologic stage N1
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 1106
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Disease-Free Survival
timeFrame: 7-Year
Secondary outcomes:
measure: Locoregional-Recurrence Free Survival
timeFrame: 7-Year
measure: Distant Metastases Free Survival
timeFrame: 7-Year
measure: Overall Survival
timeFrame: 7-Year
Other outcomes:
measure: Dermatitis
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Radiation-related pneumonitis
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Major complication rate for reconstructed breast
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Occurence of contralateral in-situ or invasive breast cancer
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Major cardiac event
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Ipsilateral rib fracture
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
measure: Arm Lymphedema
timeFrame: Every 6 month during 1 years, then every 1 year till 7 years after randomization
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongro-gu
Study officials:
affiliation: Seoul National University Hospital
name: Kyung Hwan Shin, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.