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NCT Number: NCT05440149

The Postoperative Radiotherapy in N1 Breast Cancer Patients

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.

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, Jongro-gu, 03080, South Korea

Location status: Recruiting

Location contact

Bum-Sup Jang, MD. PhD.

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No PMRT for mastectomy / No regional RT for BCS

Radiation
  • 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

Radiation
  • 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 outcomes

  1. Disease-Free Survival

    Time frame: 7-Year

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

Secondary outcomes

  1. Locoregional-Recurrence Free Survival

    Time frame: 7-Year

    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.

  2. Distant Metastases Free Survival

    Time frame: 7-Year

    Time from randomization to the development of distant metastases or breast cancer-related death.

  3. Overall Survival

    Time frame: 7-Year

    Time from randomization to the death due to any cause.

Other outcomes

  1. Dermatitis

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale

  2. Radiation-related pneumonitis

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Common Terminology Criteria for Adverse Events (CTCAE) 5.0 Scale

  3. Major complication rate for reconstructed breast

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    For patients who received breast reconstruction after mastectomy

  4. Occurence of contralateral in-situ or invasive breast cancer

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Pathologic confirmation

  5. Major cardiac event

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Myocardial infarction / Ischemic heart failure / Unstable angina / Sudden death

  6. Ipsilateral rib fracture

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Symptom or radiologic diagnosis

  7. Arm Lymphedema

    Time frame: Every 6 month during 1 years, then every 1 year till 7 years after randomization

    Symptom / Diagnosis from the related-department (e.g. rehab) / Expert opinion

Study contacts

Contact information is provided by the study sponsor or research team.

Bum-Sup Jang, MD. PhD.

CONTACT

[email protected]

+82-2-2072-1161

Kyung Hwan Shin, MD. PhD.

CONTACT

[email protected]

+82-2-2072-2524

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: PORT-N1

Important dates

Study start
2022
Primary completion
2026
Study completion
2033
First posted
Jun 30, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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