Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: No internal mammary node irradiation; Radiation: internal mammary nodal irradiation

• Registration Number: NCT06559696
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

The aim of this study is to explore the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients (ypN+or supra/subclavicular lymph node positive) after neoadjuvant chemotherapy.

Detailed Description

This is a prospective, randomized phase 3 trial. Breast cancer patients with axillary lymph node-positive or supra/subclavicular lymph node metastasis underwent neoadjuvant chemotherapy were included. Patients underwent regional nodal irradiation along with breast or chest wall irradiation and randomly allocated to either IMNI or no IMNI.

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07-15
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19
• Primary Completion: 2032-07-15
• Study Completion: 2032-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 722

Inclusion Criteria

• Histologically confirmed invasive breast cancer
• Underwent neoadjuvant chemotherapy
• Eastern Cooperative Oncology Group Performance Status Scale 0-2
• ypN+ after neoadjuvant chemotherapy or supraclavicular/subclavicular lymph node metastasis before system therapy
• No distant metastases
• No internal mammary nodes metastases based on images before system therapy
• Willing to follow up
• Written,informed consent

Exclusion Criteria

• Without neoadjuvant chemotherapy
• Distant metastases
• Simultaneous bilateral breast cancer
• Pathological confirmation or imaging consideration of lymph node metastasis in the internal mammary before system therapy
• Had simultaneous or previous secondary malignancies, except for non-malignant melanoma skin cancer, papillary thyroid / follicular carcinoma, cervical carcinoma in situ, contralateral non-invasive breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No internal mammary node irradiation	No internal mammary node irradiation	chest wall/whole breast and supraclavicular+-axillary nodal irradiation
internal mammary nodal irradiation	internal mammary nodal irradiation	chest wall/whole breast and supraclavicular+-axillary nodal plus internal mammary nodal irradiation

Primary Outcome Measures

Name	Time	Method
Disease free survival	5 years	From date of enrollment until to the first recurrence in the ipsilateral breast or chestwall, the regional nodal area, or a distant site or death due to any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	From date of enrollment until the date of death from any cause.
Distant metastasis-free survival	5 years	The time of randomization to the first recurrence in a distant site.
Local-regional recurrence-free survival	5 years	The time of randomization to the first recurrence in the ipsilateral breast or chest wall and the regional nodal area.

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China