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Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Regional lymph node radiotherapy
chest/whole breast irradiation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Ruijin Hospital, Shanghai jiaotong univestigy school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RNI group

non-RNI group

Arm Description

Outcomes

Primary Outcome Measures

5 year disease free survival rate
Disease free survival rate from randomization to 5 years after radiotherapy

Secondary Outcome Measures

5 year local reginal recurrence rate
The proportion of local or regional recurrence from randomization to 5 years after radiotherapy
5 year distant metastases rate
The proportion of distant metastases occurring 5 years after radiotherapy
5 year overall survival rate
The proportion of death occurring 5 years after radiotherapy

Full Information

First Posted
July 28, 2023
Last Updated
August 3, 2023
Sponsor
Ruijin Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05976412
Brief Title
Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer
Official Title
Prospective Randomized Controlled Study on Precision Irradiation of Regional Lymph Node for Clinical High-risk pN0 Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
May 31, 2031 (Anticipated)
Study Completion Date
May 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RNI group
Arm Type
Experimental
Arm Title
non-RNI group
Arm Type
Placebo Comparator
Intervention Type
Radiation
Intervention Name(s)
Regional lymph node radiotherapy
Intervention Description
Regional lymph node radiotherapy
Intervention Type
Radiation
Intervention Name(s)
chest/whole breast irradiation
Intervention Description
chest/whole breast irradiation
Primary Outcome Measure Information:
Title
5 year disease free survival rate
Description
Disease free survival rate from randomization to 5 years after radiotherapy
Time Frame
5 year
Secondary Outcome Measure Information:
Title
5 year local reginal recurrence rate
Description
The proportion of local or regional recurrence from randomization to 5 years after radiotherapy
Time Frame
5 year
Title
5 year distant metastases rate
Description
The proportion of distant metastases occurring 5 years after radiotherapy
Time Frame
5 year
Title
5 year overall survival rate
Description
The proportion of death occurring 5 years after radiotherapy
Time Frame
5 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Ou, MD
Phone
8618801970632
Email
od12341@rjh.com.cn
Facility Information:
Facility Name
Ruijin Hospital, Shanghai jiaotong univestigy school of medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng Wang
Phone
+862164370045
Email
qwx12055@rjh.com.cn
First Name & Middle Initial & Last Name & Degree
Jiayi Chen, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Regional Lymph Node Irradiation for High-risk pN0 Breast Cancer

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