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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06559696

FMUUH-BC-2401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 722 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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722 participants in 2 patient groups

internal mammary nodal irradiation

Experimental group

Description:

chest wall/whole breast and supraclavicular+-axillary nodal plus internal mammary nodal irradiation

Treatment:

Radiation: internal mammary nodal irradiation

No internal mammary node irradiation

Active Comparator group

Description:

chest wall/whole breast and supraclavicular+-axillary nodal irradiation

Treatment:

Radiation: No internal mammary node irradiation