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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04803266
Enrollment
747
Registered
2021-03-17
Start date
2008-11-05
Completion date
2023-02-28
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

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.

Interventions

RADIATIONInternal mammary node irradiation

Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery

RADIATIONNo internal mammary node irradiation

Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Disease-free survival7 years

Secondary

MeasureTime frame
Rates of overall survival7 years
breast cancer-specific survival7 years
Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v37 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026