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

• Sponsor: Yonsei University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04803266
• Collaborator: (none)
• Enrollment: 747
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 170.9
• Patients Per Site Per Month: 4.4

Study Details

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	Intervention/Treatment	Phase
Breast Neoplasms	Radiation: Internal mammary node irradiation; Radiation: No internal mammary node irradiation	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: Nov 5, 2008
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 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 [7 years]

Secondary Outcome Measures

1. Rates of overall survival [7 years]

2. breast cancer-specific survival [7 years]

3. Number of patients with treatment-related toxicities as assessed by RTOG/EORTC Toxicity criteria and NCI CTCAE v3 [7 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT04803266
• Other Study ID Numbers: 4-2008-0263
• First Posted: Mar 17, 2021
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

No Results Posted as of Mar 17, 2021