Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients

Phase 3

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

• Registration Number: NCT04320979
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to evaluate the impact of internal mammary nodal irradiation on disease-free survival in high-risk breast cancer patients treated with mastectomy.

Detailed Description

Eligible patients are randomized into 2 groups: chest wall and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall and supraclavicular nodal +-axillary nodal irradiation. The prescription dose is 50 Gy in 25 fractions over 5 weeks or 43.5Gy in 15 fractions over 3 weeks.

During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-05-08
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• Eastern Cooperative Oncology Group Performance Status Scale 0-2
• Histologically confirmed invasive breast cancer
• Underwent total mastectomy and axillary dissection(10 or more axillary lymph nodes detected) and negative margins
• Patients who had ≥4 positive axillary lymph nodes; or 1-3positive axillary lymph nodes and T3-4; or 1-3positive axillary lymph nodes and T1-2, and score≥3 based on the following high risk factors: age≤40 years(score 1), primary tumor in the inner quadrant (score 1), 2-3 positive axillary lymph nodes (score 1), positive vascular invasion (score 1), re-staged based on eighth Cancer Staging System staging system(IB-IIA score 1， IIB-IIIA score 2); or ypN+ after neoadjuvant chemotherapy
• No supraclavicular or internal mammary nodes metastases based on images before system therapy
• No distant metastases
• Could tolerate radiotherapy
• Treated with chemotherapy (anthracycline and/or taxane-based combined chemotherapy, ≥6 cycles)
• Anticipated to receive endocrine therapy for 5 years if indicated
• Anticipated to receive anti-HER2 therapy for 1 years if indicated
• LVEF≥50% based on echocardiogram
• Willing to follow up
• Written,informed consent

Exclusion Criteria

• Simultaneous bilateral breast cancer
• Sentinel lymph node biopsy only without axillary dissection
• Had received internal mammary node dissection
• No imaging assessment of the internal mammary nodal before system therapy
• One-stage breast reconstruction
• Severe cardiac insufficiency; myocardial infarction or uncorrected unstable arrhythmia or uncorrected unstable angina in the last 3 months; pericardial disease
• Had history of chest wall or supraclavicular radiotherapy
• 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
internal mammary nodal irradiation	internal mammary nodal irradiation	chest wall and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
no-internal mammary nodal irradiation	no internal mammary nodal irradiation	ipsilateral chest wall and supraclavicular +-axillary nodal irradiation

Primary Outcome Measures

Name	Time	Method
disease-free survival	5 years	failure: relapse of ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause.

Secondary Outcome Measures

Name	Time	Method
overall survival	5 years	the incidence of death due to any cause.
cumulative internal mammary nodal recurrence	5 years	ipsilateral internal mammary nodal relapse during follow up.
incidence of adverse events	5 years	graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0.
cumulative locoregional recurrence	5 years	ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse during follow up.
distant metastasis	5 years	the incidence of first relapse beyond locoregional region.
contralateral non-invasive breast cancer or other malignant tumors	5 years	the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment.
major cardiovascular events	5 years	the incidence of death due to coronary heart disease or other heart disease, development of myocardial infarction, coronary recanalization, or hospitalization for a major cardiovascular events (such as heart failure, valvular disease, arrhythmia, unstable angina, or other major cardiovascular event).
quality of life	5 years	questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China