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

Breast Cancer Clinical Trial

— RIGAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04069884
• Other study ID #: RIGAIN
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: June 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Xiaobo Huang, MD
• Phone: 8613556080080
• Email: huangxb[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: December 31, 2030
• Est. primary completion date: August 20, 2029
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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: ?Axillary lymph node micrometastasis (N1mic) or ?N1 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Radiation

Intervention

Radiation:
• regional nodal irradiation
external-beam radiotherapy (XRT)
• WBI
Whole Breast Irradiation
• chestwall XRT
chestwall irradiation

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (9)

Cheng SH, Horng CF, Clarke JL, Tsou MH, Tsai SY, Chen CM, Jian JJ, Liu MC, West M, Huang AT, Prosnitz LR. Prognostic index score and clinical prediction model of local regional recurrence after mastectomy in breast cancer patients. Int J Radiat Oncol Biol — View Citation

Cheng SH, Horng CF, Huang TT, Huang ES, Tsou MH, Shi LS, Yu BL, Chen CM, Huang AT. An Eighteen-Gene Classifier Predicts Locoregional Recurrence in Post-Mastectomy Breast Cancer Patients. EBioMedicine. 2016 Feb 16;5:74-81. doi: 10.1016/j.ebiom.2016.02.022. — View Citation

Cheng SH, Horng CF, West M, Huang E, Pittman J, Tsou MH, Dressman H, Chen CM, Tsai SY, Jian JJ, Liu MC, Nevins JR, Huang AT. Genomic prediction of locoregional recurrence after mastectomy in breast cancer. J Clin Oncol. 2006 Oct 1;24(28):4594-602. doi: 10 — View Citation

Cheng SH, Huang TT, Cheng YH, Tan TBK, Horng CF, Wang YA, Brian NS, Shih LS, Yu BL. Validation of the 18-gene classifier as a prognostic biomarker of distant metastasis in breast cancer. PLoS One. 2017 Sep 8;12(9):e0184372. doi: 10.1371/journal.pone.01843 — View Citation

Cheng SH, Tsai SY, Yu BL, Horng CF, Chen CM, Jian JJ, Chu NM, Tsou MH, Liu MC, Huang AT, Prosnitz LR. Validating a prognostic scoring system for postmastectomy locoregional recurrence in breast cancer. Int J Radiat Oncol Biol Phys. 2013 Mar 15;85(4):953-8 — View Citation

Huang E, Cheng SH, Dressman H, Pittman J, Tsou MH, Horng CF, Bild A, Iversen ES, Liao M, Chen CM, West M, Nevins JR, Huang AT. Gene expression predictors of breast cancer outcomes. Lancet. 2003 May 10;361(9369):1590-6. doi: 10.1016/S0140-6736(03)13308-9. — View Citation

Huang TT, Chen AC, Lu TP, Lei L, Cheng SH. Clinical-Genomic Models of Node-Positive Breast Cancer: Training, Testing, and Validation. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):637-648. doi: 10.1016/j.ijrobp.2019.06.2546. Epub 2019 Jul 8. — View Citation

Huang TT, Pennarun N, Cheng YH, Horng CF, Lei J, Hung-Chun Cheng S. Gene expression profiling in prognosis of distant recurrence in HR-positive and HER2-negative breast cancer patients. Oncotarget. 2018 May 1;9(33):23173-23182. doi: 10.18632/oncotarget.25 — View Citation

Pittman J, Huang E, Dressman H, Horng CF, Cheng SH, Tsou MH, Chen CM, Bild A, Iversen ES, Huang AT, Nevins JR, West M. Integrated modeling of clinical and gene expression information for personalized prediction of disease outcomes. Proc Natl Acad Sci U S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive disease-free survival (IDFS)	defined as the time between randomization and either local recur, distant metastases or death occurred	5 years
Secondary	Any first recurrence (AFR)	defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology	5 years
Secondary	Local-regional recurrence free survival (LRFS)	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
Secondary	Distant metastasis free survival (DMFS)	defined as time between randomization and the time of distant metastases, or death occurred	5 years
Secondary	Recurrence free survival (RFS)	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
Secondary	Overall Survival (OS)	defined as time between randomization and the time of death occurred	5 years
Secondary	Disease free survival (DFS)	defined as time between randomization and the time of disease recur or death occur	5 years
Secondary	Beast cancer specific mortality (BCSM)	defined as time between randomization and the time of death occur specific due to breast cancer	5 years
Secondary	Patient life quality measurement	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
Secondary	Patient life quality measurement	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