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

January 6, 2022 updated by: Shu lian Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: internal mammary nodal irradiation
chest wall and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
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).
Active Comparator: no-internal mammary nodal irradiation
ipsilateral chest wall and supraclavicular +-axillary nodal irradiation
Radiation: no internal mammary nodal irradiation
chest wall and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease-free survival
Time Frame: 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.
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

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

Investigators

  • Study Chair: Ye-xiong Li, M.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2020

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/317-2101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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