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

NCT ID: NCT04803266

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

747 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-05

Study Completion Date

2023-02-28

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internal mammary node irradiation

Group Type EXPERIMENTAL

Internal mammary node irradiation

Intervention Type RADIATION

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

No internal mammary node irradiation

Group Type ACTIVE_COMPARATOR

No internal mammary node irradiation

Intervention Type RADIATION

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

Interventions

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Internal mammary node irradiation

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

Intervention Type RADIATION

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Bae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Yonsei Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim YB, Byun HK, Kim DY, Ahn SJ, Lee HS, Park W, Kim SS, Kim JH, Lee KC, Lee IJ, Kim WT, Shin HS, Kim K, Shin KH, Nam CM, Suh CO. Effect of Elective Internal Mammary Node Irradiation on Disease-Free Survival in Women With Node-Positive Breast Cancer: A Randomized Phase 3 Clinical Trial. JAMA Oncol. 2022 Jan 1;8(1):96-105. doi: 10.1001/jamaoncol.2021.6036.

Reference Type DERIVED
PMID: 34695841 (View on PubMed)

Other Identifiers

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4-2008-0263

Identifier Type: -

Identifier Source: org_study_id

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