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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT04803266

  • Recruitment Status

    Active, not recruiting

  • First Posted

    March 17, 2021

  • Last update posted

    March 17, 2021

Study Description

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.

  • Condition or Disease:Breast Neoplasms
  • Intervention/Treatment: Radiation: Internal mammary node irradiation
    Radiation: No internal mammary node irradiation
  • Phase: Phase 3

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 747 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Elective Internal Mammary Node Irradiation in Women With Node-positive Breast Cancer: a Randomized, Phase 3 Trial
  • Actual Study Start Date: November 2008
  • Estimated Primary Completion Date: February 2023
  • Estimated Study Completion Date: February 2023

Arms and interventions

Arm Intervention/treatment
Experimental: Internal mammary node irradiation
Radiation: Internal mammary node irradiation
Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
Active Comparator: No internal mammary node irradiation
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

Outcome Measures

  • Primary Outcome Measures: 1. Disease-free survival [ Time Frame: 7 years ]
  • Secondary Outcome Measures: 1. Rates of overall survival [ Time Frame: 7 years ]
  • 2. breast cancer-specific survival [ Time Frame: 7 years ]
  • 3. Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3 [ Time Frame: 7 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Locations

Korea, Republic of
Yonsei Severance Hospital
Seoul

Sponsors and Collaborators

Yonsei University

Investigators

Principal Investigator: Yong Bae Kim, MD, PhD Severance Hospital

More Information

  • Responsible Party: Yonsei University
  • ClinicalTrials.gov Identifier: NCT04803266 History of Changes
  • Other Study ID Numbers: 4-2008-0263
  • First Posted: March 17, 2021 Key Record Dates
  • Last Update Posted: March 17, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Undecided
  • Plan Description: Analytic codes will be shared upon reasonable request to corresponding author.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Breast Neoplasms