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

Breast Cancer Clinical Trial

Official title:

Postmastectomy Prophylactic Internal Mammary Nodal Irradiation for High-risk Patients With Non-metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320979
• Other study ID #: 19/317-2101
• Status: Recruiting
• Phase: Phase 3
• Start date: May 8, 2020
• Est. completion date: May 2024

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Shu-lian Wang, M.D
• Phone: 8610-87788803
• Email: wangsl[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• internal mammary nodal irradiation
chest wall and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).
• no internal mammary nodal irradiation
chest wall and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing

Sponsors (25)

Lead Sponsor

Collaborator

Chinese Academy of Medical Sciences

Air Force Military Medical University, China, Anyang Tumor Hospital, Beijing Cancer Hospital, Beijing Hospital, China-Japan Union Hospital, Jilin University, Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital Xi'an Jiaotong University, Fudan University, Guizhou people's Hospital, Hebei Medical University Fourth Hospital, Henan Cancer Hospital, Jilin Provincial Tumor Hospital, Liaoning Tumor Hospital & Institute, Peking Union Medical College Hospital, Shanghai Zhongshan Hospital, Shanxi Dayi Hospital, Shanxi Province Cancer Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Taizhou Hospital of Zhejiang Province, Tangshan People's Hospital, The First Hospital of Jilin University, West China Hospital, Wuhan University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	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.	5 years
Secondary	overall survival	the incidence of death due to any cause.	5 years
Secondary	cumulative internal mammary nodal recurrence	ipsilateral internal mammary nodal relapse during follow up.	5 years
Secondary	cumulative locoregional recurrence	ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse during follow up.	5 years
Secondary	distant metastasis	the incidence of first relapse beyond locoregional region.	5 years
Secondary	contralateral non-invasive breast cancer or other malignant tumors	the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment.	5 years
Secondary	major cardiovascular events	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).	5 years
Secondary	incidence of adverse events	graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0.	5 years
Secondary	quality of life	questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale	5 years