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Clinical Trials in China / NCT05976412
Recruiting Not applicable

Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

NCT05976412 · tracked via the Priya Life Science China tracker
Sponsor
Ruijin Hospital
Phase
Not applicable
Started
2023-07-28
Last updated
2023-08-07

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Regional lymph node radiotherapychest/whole breast irradiation

Regional lymph node radiotherapy: Regional lymph node radiotherapy

chest/whole breast irradiation: chest/whole breast irradiation

Study summary

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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine Shanghai Shanghai Municipality Recruiting

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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 NCT05976412 on ClinicalTrials.gov ↗ ← All trials in China