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Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Recruiting
18 years and older
Female
Phase N/A

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Overview

This study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pN0 breast cancer patients.

Eligibility

Inclusion Criteria:

        Voluntarily participate and sign an informed consent form; Age>18 years old, female;
        received radical surgery for breast cancer, including breast conservation surgery or
        mastectomy, combined with Sentinel lymph node biopsy or axillary lymph node dissection;
        Invasive cancer, postoperative axillary lymph node negative, with pathological staging of
        T1-3N0M0 stage (Stage IA, IIA, IIB); including two or more high-risk factors based on four
        clinical high-risk recurrence factors [tumor size (>2cm), tumor site (medial and central
        quadrants), Ki-67 level (>14%), and vascular status (positive)]; KPS ≥ 80, estimated
        survival time >5 years; Complete healing of Surgical incision, no incision infection, etc;
        Reproductive period women should undergo contraception for at least one month before study,
        and promise to use contraception throughout the entire study period and continue until the
        specified time after the end of the study
        Exclusion Criteria:
        Pregnant or lactating women; Received neoadjuvant therapy; with serious non neoplastic
        medical complications that affect the implementation of radiotherapy; History of malignant
        tumor in the past 5 years (excluding previous lobular Carcinoma in situ, skin Basal-cell
        carcinoma, skin Carcinoma in situ, cervical Carcinoma in situ and lung Carcinoma in situ);
        Simultaneous contralateral breast cancer; Previous history of neck, chest, or ipsilateral
        axillary radiotherapy; Active collagen vascular disease; distant metastasis confirmed by
        pathology or imaging;

Study details
    Breast Cancer

NCT05976412

Ruijin Hospital

26 January 2024

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