Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

NCT05976412 | Recruiting

• 1 other identifier: 2023（148）
• Study Type: interventional
• Target: 1,355
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 5 year disease free survival rate

  Disease free survival rate from randomization to 5 years after radiotherapy

  5 year

Secondary Outcomes (3)

• 5 year local reginal recurrence rate

  5 year

• 5 year distant metastases rate

  5 year

• 5 year overall survival rate

  5 year

Study Arms (2)

RNI group

EXPERIMENTAL

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

non-RNI group

PLACEBO COMPARATOR

Radiation: chest/whole breast irradiation

Interventions

Regional lymph node radiotherapy RADIATION

Regional lymph node radiotherapy

RNI group

chest/whole breast irradiation RADIATION

chest/whole breast irradiation

RNI group; non-RNI group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dan Ou, MD

CONTACT

8618801970632; od12341@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): May 31, 2031
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

CN (1)