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Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

omit of IMI group

IMI group

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, N1, clinical-genomic model, genomic model, radiotherapy, internal mammary irradiation, clinical model

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• Histologically confirmed invasive breast cancer
- Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)
- The number of positive lymph node should be 1-3 (N1).
- Clinical high risk breast cancer (≥2 clinical risk factors)
- Aged 18-80 years old
- ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival >5 years Pathologically surgical margin >2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form

Exclusion Criteria:

• Axillary dissection of less than 10 lymph nodes
- Pathologically positive ipsilateral supraclavicular lymph node
- Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
- Pregnant or lactating women
- Treated with breast reconstruction surgery
- Severe non-neoplastic medical comorbidities
- History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix
- simultaneous contralateral breast cancer
- Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
- Active collagen vascular disease
- Definitive pathological or radiologic evidence of distant metastatic disease
- Primary T4 tumor
- Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks

Sites / Locations

Ruijin Hospital, Shanghai jiaotong univestigy school of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

controlled group

Arm Description

whole breast/chest wall irradiation + SVC irradiation

whole breast/chest wall irradiation + IMI+SVC irradiation

Outcomes

Primary Outcome Measures

2-year event-free survival

any recurrence,distant metastasis or death in 2 years

Secondary Outcome Measures

5-year event-free survival

any local recurrence, distant metastasis or death in 5 years

5-year overall survival

death in 5 years

5-year Locoregional recurrence (LRR)

any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area (including supraclavicular, infraclavicular or internal mammary lymph nodes)

Full Information

NCT ID

NCT04517266

First Posted

August 12, 2020

Last Updated

September 14, 2022

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04517266

Brief Title

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

Official Title

Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer Patients According to Clinical-genomic Model: an Open Label, Non-inferior Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

October 30, 2025 (Anticipated)

Study Completion Date

October 30, 2030 (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

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The effect of internal mammary irradiation (IMI) added to whole-breast or thoracic-wall irradiation plus supraclavicular (SVC) irradiation after surgery on survival among women with early-stage intermediate risk (N1) breast cancer remains debated. The present study aimed to identified patient could be omitted from internal mammary lymph node irradiation by using a clinical-genomic model.

Detailed Description

This study is a phase II open label, non-inferior randomized controlled trial, we aimed to compare the safety and effectiveness difference of whole breast/chest wall irradiation + IMI+SVC irradiation vs whole breast/chest wall irradiation + SVC irradiation among clinical high risk, genomic low risk of N1 breast cancer. In previous studies, 28 gene classifier has been developed and established to predict local/regional recurrence. The 28 gene classifier was combined with 18 cancer gene and 10 reference gene. The 18 cancer gene includes BLM, TCF3, PIM1, RCHY1, PTI1,DDX39, BUB1B, STIL, TPX2, CCNB1,MMP15, CCR1,NFATC2IP, TRPV6,OBSL1, C16ORF7,DTX2, and ENSA. The expression of RCHY1, PTI1, ENSA, and TRPV6 is associated with better tumor biology and disease control. The remaining 14 genes are associated with poor outcomes. By using the 18-gene scoring algorithm defines the risk of recurrence as: low risk or high risk. A total of five clinical factors [age（≤40 vs. >40, number of positive lymph node（1-2 vs. 3）, grade(I-II vs. III), tumor size (T1-T2), ki-67(<14% vs. ≥14%)] were identified to be significantly associated with outcomes of breast cancer in our previous study. And patients with more than 2 risk factors were defined as clinical high risk. Clinical high risk participants (≥2 factors) with low-risk scores will be randomized to whole breast/chest wall irradiation + IMI+SVC irradiation or whole breast/chest wall irradiation + SVC irradiation

6. Conditions and Keywords

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

Breast Cancer

Keywords

breast cancer, N1, clinical-genomic model, genomic model, radiotherapy, internal mammary irradiation, clinical model

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

experimental group

Arm Type

Experimental

Arm Description

whole breast/chest wall irradiation + SVC irradiation

Arm Title

controlled group

Arm Type

Active Comparator

Arm Description

whole breast/chest wall irradiation + IMI+SVC irradiation

Intervention Type

Radiation

Intervention Name(s)

omit of IMI group

Intervention Description

clincial high risk breast （≥2 risk factors）patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.

Intervention Type

Radiation

Intervention Name(s)

IMI group

Intervention Description

Primary Outcome Measure Information:

Title

2-year event-free survival

Description

any recurrence,distant metastasis or death in 2 years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

5-year event-free survival

Description

any local recurrence, distant metastasis or death in 5 years

Time Frame

5 years

Title

5-year overall survival

Description

death in 5 years

Time Frame

5 years

Title

5-year Locoregional recurrence (LRR)

Description

any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area (including supraclavicular, infraclavicular or internal mammary lymph nodes)

Time Frame

5-years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • Histologically confirmed invasive breast cancer Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND) The number of positive lymph node should be 1-3 (N1). Clinical high risk breast cancer (≥2 clinical risk factors) Aged 18-80 years old ECOG performance status ≤2 (Karnofsky ≥70%) Anticipative overall survival >5 years Pathologically surgical margin >2mm ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation Ability to understand and willingness to participate the research and sign the consent form Exclusion Criteria: • Axillary dissection of less than 10 lymph nodes Pathologically positive ipsilateral supraclavicular lymph node Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes Pregnant or lactating women Treated with breast reconstruction surgery Severe non-neoplastic medical comorbidities History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix simultaneous contralateral breast cancer Previous radiotherapy to the neck, chest and/or ipsilateral axillary region Active collagen vascular disease Definitive pathological or radiologic evidence of distant metastatic disease Primary T4 tumor Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-Xiang Qi, Dr.

Phone

+862164370045

qiweixiang1113@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei-Xiang Qi, Dr.

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27077114

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. eCollection 2016 Mar.

Results Reference

background

PubMed Identifier

17008701

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: 10.1200/JCO.2005.02.5676.

Results Reference

background

PubMed Identifier

31812892

Citation

Qi WX, Cao L, Xu C, Zhao S, Chen J. Adjuvant regional nodal irradiation did not improve outcomes in T1-2N1 breast cancer after breast-conserving surgery: A propensity score matching analysis of BIG02/98 and BCIRG005 trials. Breast. 2020 Feb;49:165-170. doi: 10.1016/j.breast.2019.11.001. Epub 2019 Nov 29.

Results Reference

background

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Evaluating Omitting of Internal Mammary Irradiation Among Early Stage Intermediate Risk (N1) Breast Cancer

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