Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
NCT Number: NCT05976412
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200025, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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;
Regional lymph node radiotherapy
chest/whole breast irradiation
Time frame: 5 year
Disease free survival rate from randomization to 5 years after radiotherapy
Time frame: 5 year
The proportion of local or regional recurrence from randomization to 5 years after radiotherapy
Time frame: 5 year
The proportion of distant metastases occurring 5 years after radiotherapy
Time frame: 5 year
The proportion of death occurring 5 years after radiotherapy
Contact information is provided by the study sponsor or research team.
Ruijin Hospital
Other
Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
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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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