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

Internal Mammary Lymph Nodes Irradiation in High-risk Breast Cancer After Neoadjuvant Chemotherapy: a Phase III Randomized, Controlled Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06559696

Enrollment

722

Registered

2024-08-19

Start date

2024-07-15

Completion date

2032-07-15

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Internal mammary nodal, Radiation

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.

Interventions

RADIATIONinternal mammary nodal irradiation

chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

RADIATIONNo internal mammary node irradiation

chest wall/whole breast and supraclavicular +-axillary irradiation (50 Gy in 25 fractions or 40Gy in 15 fractions).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactYong Yang, M.S

dr_yangyong1983@163.com18813019084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026