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

Seoul National University logo

Seoul National University

Status and phase

Enrolling
Phase 3

Conditions

Breast Cancer
Radiotherapy

Treatments

Radiation: No PMRT for mastectomy / No regional RT for BCS
Radiation: PMRT for mastectomy / WBI + Regional RT for BCS

Study type

Interventional

Funder types

Other

Identifiers

NCT05440149
0720222005

Details and patient eligibility

About

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.

Full 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

Enrollment

1,106 estimated patients

Sex

Female

Ages

19+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,106 participants in 2 patient groups

The Control group
Active Comparator group
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.
Treatment:
Radiation: PMRT for mastectomy / WBI + Regional RT for BCS
The Experimental group
Experimental group
Description:
If patients received mastectomy, No PMRT should be performed. If patients received BCS, WBI alone should be performed.
Treatment:
Radiation: No PMRT for mastectomy / No regional RT for BCS

Trial contacts and locations

1

Loading...

Central trial contact

Kyung Hwan Shin, MD. PhD.; Bum-Sup Jang, MD. PhD.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems