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NCT04803266 Clinical Trial

Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer

Breast Neoplasms Clinical Trial

Official title:
Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04803266
Other study ID # 4-2008-0263
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 5, 2008
Est. completion date February 2023

Study information
Verified date March 2021
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to find out whether the inclusion of internal mammary node irradiation in regional nodal irradiation improves outcomes in women with node-positive breast cancer.

Description:

This is a multicenter, prospective, randomized phase 3 trial. Patients with node-positive breast cancer without distant metastases were included. All patients underwent breast conservation surgery or mastectomy with axillary lymph node dissection before irradiation. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 747
Est. completion date February 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Women with histologically confirmed node-positive breast cancer who had undergone modified radical mastectomy or breast-conserving surgery and axillary dissection with =8 nodes removed. Exclusion Criteria: 1. Neoadjuvant chemotherapy 2. Bilateral breast cancer 3. Distant metastasis 4. History of other malignancy 5. Involvement of supraclavicular nodes or internal mammary nodes at diagnosis

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Internal mammary node irradiation
Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
• No internal mammary node irradiation
Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery

Locations
Country Name City State
Korea, Republic of Yonsei Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free survival 7 years
Secondary Rates of overall survival 7 years
Secondary breast cancer-specific survival 7 years
Secondary Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3 7 years
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