The Postoperative Radiotherapy in N1 Breast Cancer Patients

NCT05440149 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Phase 3

Started

2022-08-01

Last updated

2024-11-29

Condition(s) studied

RadiotherapyBreast Cancer

Investigational drug(s) / intervention(s)

No PMRT for mastectomy / No regional RT for BCSPMRT for mastectomy / WBI + Regional RT for BCS

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

19 Years

Max age

—

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.

Primary outcome measure(s)

Disease-Free Survival — 7-Year
Time from randomization to local recurrence, regional recurrence, distant metastases, or breast cancer-related death.

Trial sites (1)

Facility	City	Region	Status
Seoul National University Hospital	Seoul	Jongro-gu	Recruiting

More Seoul National University Hospital trials in South Korea

Lung Cancer Surgery in Sarcopenia Patients With Old Age Active, not recruiting

Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION) Recruiting

Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis Recruiting

Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Recruiting

Reduction of Remifentanil-related Complications Starting soon

Other trials for the same condition

A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Recruiting

A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor. Active, not recruiting

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer Recruiting

Prospective Cohort for Tumor Bed Boost Radiotherapy in HER2 Positive Breast Cancer Recruiting

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05440149 on ClinicalTrials.gov ↗ ← All trials in South Korea