RecurIndex Guided Avoidance of Regional Nodal Irradiation for Node Positive Breast Cancer (RIGAIN)

June 26, 2023 updated by: Xiaobo Huang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaobo Huang, MD
        • Sub-Investigator:
          • Yuting Tan
        • Sub-Investigator:
          • Fengxi Su, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years old, ≤ 70 years old.
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2.
  • Postoperative pathology is clearly diagnosed as invasive breast cancer.
  • Meet the clinical definition of low risk: ①Axillary lymph node micrometastasis (N1mic) or ②N1 patients who meet the following conditions at the same time, a）Age ≥ 40 years old, b）Vascular tumor thrombus (LVI) negative or allow few positive LVI (excluding extensive or massive LVI), c）Three subtypes are allowed (Lumina A, Lumina B/HER2 negative, Lumina B/HER2 positive) , namely ER positive (ER ≥ 1%), HER2 negative (HER2 expression negative or + by IHC, or 2+ but negative by FISH) or ER positive (ER ≥ 1%), HER2 positive (3+ by IHC, or 2+ but positive by FISH).
  • Postoperative pathological diagnosis of axillary lymph node status is any of the following: a. Sentinel lymph node biopsy or axillary lymph node dissection for micrometastasis (N1mic), b. Sentinel lymph node biopsy for 1-2 lymph node macrometastasis (N1sln), c. Sentinel lymph node biopsy + axillary lymph node dissection or simple axillary lymph node dissection for 1-3 lymph node metastasis (N1).
  • The primary tumor and breast undergo breast-conserving surgery or total resection ± breast reconstruction (autologous/prosthetic).
  • There must be adequate systemic examination (such as chest X-ray, B-ultrasound, CT, etc.) within 3 months before randomization of radiotherapy to confirm that there is no distant metastasis.
  • No contralateral breast cancer must be confirmed by molybdenum target and/or MRI within 12 months before randomization of radiotherapy.
  • At least 4 courses of adjuvant chemotherapy with anthracycline or taxane should be completed after surgery.
  • Radiotherapy must be performed sequentially after the completion of adjuvant chemotherapy, starting no later than 8 weeks after the end of chemotherapy.
  • The patient must have sufficient primary fresh frozen specimens or post-paraffin tissue sections for RecurIndex testing.
  • No previous history of malignant tumors, except for basal cell carcinoma of the skin.
  • Signed an informed consent form.

Exclusion Criteria:

  • Postoperative radiotherapy was confirmed as T3-4, N0, N2-3, M1 lesion staging before enrollment.
  • Receive any new adjuvant therapy before surgery, including chemotherapy, endocrine therapy, targeted therapy or radiation therapy.
  • Patients who underwent total mastectomy and only sentinel lymph node biopsy.
  • Have a history of contralateral breast cancer.
  • History of chest radiotherapy.
  • combined with severe heart, lung, liver, kidney, hematopoietic, neurological diseases, and mental illness.
  • History of autoimmune diseases such as scleroderma or active lupus erythematosus.
  • pregnant and lactating patients.
  • Unable or unwilling to sign an informed consent form.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (Clinical low-risk, RecurIndex high-risk)
Regional nodal irradiation (RNI) was given along with whole breast irradiation (WBI) or Chest wall irradiation (CWI) for breast-conserving patients and total mastectomy patients, respectively.
Radiation: regional nodal irradiation
external-beam radiotherapy (XRT)
Radiation: WBI
Whole Breast Irradiation
Radiation: chestwall XRT
chestwall irradiation
Active Comparator: Arm II (Clinical low-risk, RecurIndex high-risk)
No Regional nodal irradiation (RNI) , whole breast irradiation (WBI) for breast-conserving patients and No Chest wall irradiation (CWI) for total mastectomy patients.
Radiation: WBI
Whole Breast Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive disease-free survival (IDFS)
Time Frame: 5 years
defined as the time between randomization and either local recur, distant metastases or death occurred
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival (RFS)
Time Frame: 5 years
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
5 years
Any first recurrence (AFR)
Time Frame: 5 years
defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology
5 years
Local-regional recurrence free survival (LRFS)
Time Frame: 5 years
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
5 years
Distant metastasis free survival (DMFS)
Time Frame: 5 years
defined as time between randomization and the time of distant metastases, or death occurred
5 years
Overall Survival (OS)
Time Frame: 5 years
defined as time between randomization and the time of death occurred
5 years
Disease free survival (DFS)
Time Frame: 5 years
defined as time between randomization and the time of disease recur or death occur
5 years
Beast cancer specific mortality (BCSM)
Time Frame: 5 years
defined as time between randomization and the time of death occur specific due to breast cancer
5 years
Patient life quality measurement
Time Frame: 5 years
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer-30 (C30)
5 years
Patient life quality measurement
Time Frame: 5 years
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23)
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Collaborators

Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Estimated)

August 20, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 24, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIGAIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

individual patient data (IPD) will be shared when the research is published.

IPD Sharing Time Frame

The data will become available in 2030 and forever.

IPD Sharing Access Criteria

Study Protocol

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on regional nodal irradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe