Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Breast Cancer Clinical Trial

Official title:

Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976412
• Other study ID #: 2023(148)
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2023
• Est. completion date: May 31, 2031

Study information

• Verified date: August 2023
• Source: Ruijin Hospital
• Contact: Dan Ou, MD
• Phone: 8618801970632
• Email: od12341[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1355
• Est. completion date: May 31, 2031
• Est. primary completion date: May 31, 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Regional lymph node radiotherapy
Regional lymph node radiotherapy
• chest/whole breast irradiation
chest/whole breast irradiation

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai jiaotong univestigy school of medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5 year disease free survival rate	Disease free survival rate from randomization to 5 years after radiotherapy	5 year
Secondary	5 year local reginal recurrence rate	The proportion of local or regional recurrence from randomization to 5 years after radiotherapy	5 year
Secondary	5 year distant metastases rate	The proportion of distant metastases occurring 5 years after radiotherapy	5 year
Secondary	5 year overall survival rate	The proportion of death occurring 5 years after radiotherapy	5 year