The Postoperative Radiotherapy in N1 Breast Cancer Patients

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440149
• Other study ID #: 0720222005
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2022
• Est. completion date: December 31, 2033

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Kyung Hwan Shin, MD. PhD.
• Phone: +82-2-2072-2524
• Email: radiat[@]snu.ac.kr, shinkh[@]snuh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1106
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiotherapy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongro-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Ipsilateral rib fracture	Symptom or radiologic diagnosis	Every 6 month during 1 years, then every 1 year till 7 years after randomization
Other	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
Primary	Disease-Free Survival	Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.	7-Year
Secondary	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
Secondary	Distant Metastases Free Survival	Time from randomization to the development of distant metastases or breast cancer-related death.	7-Year
Secondary	Overall Survival	Time from randomization to the death due to any cause.	7-Year