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

Primary Purpose

Radiotherapy, Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
No PMRT for mastectomy / No regional RT for BCS
PMRT for mastectomy / WBI + Regional RT for BCS
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiotherapy focused on measuring Breast Cancer, Radiotherapy, Omission, Breast Conserving Surgery, Mastectomy, TNM pathologic stage N1

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The Control group

The Experimental group

Arm Description

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.

If patients received mastectomy, No PMRT should be performed. If patients received BCS, WBI alone should be performed.

Outcomes

Primary Outcome Measures

Disease-Free Survival
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.

Secondary Outcome Measures

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.
Distant Metastases Free Survival
Time from randomization to the development of distant metastases or breast cancer-related death.
Overall Survival
Time from randomization to the death due to any cause.

Full Information

First Posted
June 27, 2022
Last Updated
August 28, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05440149
Brief Title
The Postoperative Radiotherapy in N1 Breast Cancer Patients
Acronym
PORT-N1
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiotherapy, Breast Cancer
Keywords
Breast Cancer, Radiotherapy, Omission, Breast Conserving Surgery, Mastectomy, TNM pathologic stage N1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Control group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
The Experimental group
Arm Type
Experimental
Arm Description
If patients received mastectomy, No PMRT should be performed. If patients received BCS, WBI alone should be performed.
Intervention Type
Radiation
Intervention Name(s)
No PMRT for mastectomy / No regional RT for BCS
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
PMRT for mastectomy / WBI + Regional RT for BCS
Intervention Description
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 Measure Information:
Title
Disease-Free Survival
Description
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.
Time Frame
7-Year
Secondary Outcome Measure Information:
Title
Locoregional-Recurrence Free Survival
Description
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.
Time Frame
7-Year
Title
Distant Metastases Free Survival
Description
Time from randomization to the development of distant metastases or breast cancer-related death.
Time Frame
7-Year
Title
Overall Survival
Description
Time from randomization to the death due to any cause.
Time Frame
7-Year
Other Pre-specified Outcome Measures:
Title
Dermatitis
Description
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Radiation-related pneumonitis
Description
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Major complication rate for reconstructed breast
Description
For patients who received breast reconstruction after mastectomy
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Occurence of contralateral in-situ or invasive breast cancer
Description
Pathologic confirmation
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Major cardiac event
Description
Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Ipsilateral rib fracture
Description
Symptom or radiologic diagnosis
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization
Title
Arm Lymphedema
Description
Symptom / Diagnosis from the related-department (e.g. rehab) / Expert opinion
Time Frame
Every 6 month during 1 years, then every 1 year till 7 years after randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyung Hwan Shin, MD. PhD.
Phone
+82-2-2072-2524
Email
radiat@snu.ac.kr, shinkh@snuh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bum-Sup Jang, MD. PhD.
Phone
+82-2-2072-1161
Email
bigwiz83@snu.ac.kr, bigwiz83@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Hwan Shin, MD. PhD.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongro-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bum-Sup Jang, MD. PhD.
Email
bigwiz83@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36384573
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.
Results Reference
derived

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The Postoperative Radiotherapy in N1 Breast Cancer Patients

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