Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

NCT ID: NCT05976412

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2031-05-31

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RNI group

Group Type: EXPERIMENTAL

Regional lymph node radiotherapy

Intervention Type: RADIATION

Regional lymph node radiotherapy

chest/whole breast irradiation

Intervention Type: RADIATION

chest/whole breast irradiation

non-RNI group

Group Type: PLACEBO_COMPARATOR

chest/whole breast irradiation

Intervention Type: RADIATION

chest/whole breast irradiation

Interventions

Regional lymph node radiotherapy

Regional lymph node radiotherapy

Intervention Type: RADIATION

chest/whole breast irradiation

chest/whole breast irradiation

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

JIAYI CHEN

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dan Ou, MD

Role: CONTACT

od12341@rjh.com.cn

8618801970632

Facility Contacts

Yifeng Wang

Role: primary

qwx12055@rjh.com.cn

+862164370045

Other Identifiers

2023（148）

Identifier Type: -

Identifier Source: org_study_id