The Postoperative Radiotherapy after Breast Conserving Surgery or Mastectomy in N1 Breast Cancer Patients: A Prospective, Multicenter, Phase III Clinical Trial (PORT-N1)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0007504

Enrollment

1106

Registered

2022-07-18

Start date

2022-07-19

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : 1:1 Radomization to the control group and experimental group, stratified by the type of surgery (breast-conserving surgery versus mastectomy) and the type of histologic type (triple negati

Eligibility

Sex/Gender

Female

Inclusion 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 HER-2 positive. -Patients with Eastern Cooperative Oncology Group (ECOG) Scale 0-2. -Patients who agreed to participate in the study.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Disease-Free Survival	—

Secondary

Measure	Time frame
Locoregional-Recurrence Free Survival;Distant-Free Survival;Overall Survival	—

Countries

Korea, Republic of

Contacts

Public ContactBum-Sup Jang

Seoul National University Hospital

bigwiz83@gmail.com+82-2-2072-1161

Outcome results