The Postoperative Radiotherapy in N1 Breast Cancer Patients (PORT-N1)

The Postoperative Radiotherapy After Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: a Prospective, Multicenter, Phase III Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy
• Intervention / Treatment: Radiation: PMRT for mastectomy / WBI + Regional RT for BCS; Radiation: No PMRT for mastectomy / No regional RT for BCS

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

• Study Type: Interventional
• Enrollment (Estimated): 1106
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kyung Hwan Shin, MD. PhD.; Phone Number: +82-2-2072-2524; Email: radiat@snu.ac.kr
• Study Contact Backup: Name: Bum-Sup Jang, MD. PhD.; Phone Number: +82-2-2072-1161; Email: bigwiz83@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongro-gu
    • Seoul, Jongro-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Bum-Sup Jang, MD. PhD.; Email: bigwiz83@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: The Experimental group; If patients received mastectomy, No PMRT should be performed.; If patients received BCS, WBI alone should be performed.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-Free Survival	Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.	7-Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Locoregional-Recurrence Free Survival	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.	7-Year
Distant Metastases Free Survival	Time from randomization to the development of distant metastases or breast cancer-related death.	7-Year
Overall Survival	Time from randomization to the death due to any cause.	7-Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatitis	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Radiation-related pneumonitis	Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Major complication rate for reconstructed breast	For patients who received breast reconstruction after mastectomy	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Occurence of contralateral in-situ or invasive breast cancer	Pathologic confirmation	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Major cardiac event	Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Ipsilateral rib fracture	Symptom or radiologic diagnosis	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Arm Lymphedema	Symptom / Diagnosis from the related-department (e.g. rehab) / Expert opinion	Every 6 month during 1 years, then every 1 year till 7 years after randomization

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Kyung Hwan Shin, MD. PhD., Seoul National University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Conserving Surgery; Radiotherapy; Mastectomy; Omission; TNM pathologic stage N1
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 0720222005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No