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

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Breast Neoplasms

Treatments: Radiation: No internal mammary node irradiation; Radiation: Internal mammary node irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT04803266

4-2008-0263

Details and patient eligibility

About

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.

Full 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.

Enrollment: 747 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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747 participants in 2 patient groups

Internal mammary node irradiation

Experimental group

Treatment:

Radiation: Internal mammary node irradiation

No internal mammary node irradiation

Active Comparator group

Treatment:

Radiation: No internal mammary node irradiation