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

NCT ID: NCT06559696

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

722 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2032-07-15

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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internal mammary nodal irradiation

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

Group Type EXPERIMENTAL

internal mammary nodal irradiation

Intervention Type RADIATION

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

No internal mammary node irradiation

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

Group Type ACTIVE_COMPARATOR

No internal mammary node irradiation

Intervention Type RADIATION

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

Interventions

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internal 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).

Intervention Type RADIATION

No internal mammary node irradiation

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong Yang

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong Yang, M.S

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yong Yang, M.S

Role: CONTACT

18813019084

Facility Contacts

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Yong Yang, Doctor

Role: primary

18813019084

Other Identifiers

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FMUUH-BC-2401

Identifier Type: -

Identifier Source: org_study_id

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