NCT04517266

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
54mo left

Started Mar 2021

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Mar 2021Oct 2030

First Submitted

Initial submission to the registry

August 12, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Expected
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

4.7 years

First QC Date

August 12, 2020

Last Update Submit

November 30, 2023

Conditions

Breast Cancer

Keywords

breast cancerN1clinical-genomic modelgenomic modelradiotherapyinternal mammary irradiationclinical model

Outcome Measures

Primary Outcomes (1)

  • 2-year event-free survival

    any recurrence,distant metastasis or death in 2 years

    2 years

Secondary Outcomes (3)

  • 5-year event-free survival

    5 years

  • 5-year overall survival

    5 years

  • 5-year Locoregional recurrence (LRR)

    5-years

Study Arms (2)

experimental group

EXPERIMENTAL

whole breast/chest wall irradiation + SVC irradiation

Radiation: omit of IMI group

controlled group

ACTIVE COMPARATOR

whole breast/chest wall irradiation + IMI+SVC irradiation

Radiation: IMI group

Interventions

omit of IMI groupRADIATION

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.

experimental group
IMI groupRADIATION

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.

controlled group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai jiaotong univestigy school of medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27077114BACKGROUND

  • 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.

    PMID: 17008701BACKGROUND

  • 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.

    PMID: 31812892BACKGROUND

  • Qi WX, Cao L, Zheng S, Xu C, Cai R, Xu H, Cai G, Chen J. IMNI PRECISION trial protocol: a phase II, open-label, non-inferior randomized controlled trial of tailoring omission of internal mammary node irradiation for early-stage breast cancer. BMC Cancer. 2022 Dec 27;22(1):1356. doi: 10.1186/s12885-022-10454-1.

    PMID: 36575421DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wei-Xiang Qi, Dr.

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Xiang Qi, Dr.

CONTACT

+862164370045qiweixiang1113@163.com

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
Clinical Professor

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 18, 2020

Study Start

March 1, 2021

Primary Completion

October 30, 2025

Study Completion (Estimated)

October 30, 2030

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)