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

Phase 3

• Conditions: Breast Neoplasms
• Interventions: Radiation: Internal mammary node irradiation; Radiation: No internal mammary node irradiation

• Registration Number: NCT04803266
• Lead Sponsor: Yonsei University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-11-05
• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-17
• Last Update Posted: 2021-03-17
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 747

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal mammary node irradiation	Internal mammary node irradiation	-
No internal mammary node irradiation	No internal mammary node irradiation	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival	7 years

Secondary Outcome Measures

Name	Time	Method
breast cancer-specific survival	7 years
Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3	7 years
Rates of overall survival	7 years

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of