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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
internal mammary nodal irradiation
no internal mammary nodal irradiation
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast neoplasm, mastectomy, radiotherapy, internal mammary node

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

internal mammary nodal irradiation

no-internal mammary nodal irradiation

Arm Description

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

ipsilateral chest wall and supraclavicular +-axillary nodal irradiation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 19, 2020
Last Updated
January 6, 2022
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Hebei Medical University Fourth Hospital, Shanghai Zhongshan Hospital, Zhejiang Cancer Hospital, Beijing Hospital, Liaoning Tumor Hospital & Institute, Jilin Provincial Tumor Hospital, Shanxi Province Cancer Hospital, Tangshan People's Hospital, China-Japan Union Hospital, Jilin University, The First Hospital of Jilin University, West China Hospital, Peking Union Medical College Hospital, Anyang Tumor Hospital, Guizhou people's Hospital, Henan Cancer Hospital, Wuhan University, Peking University Cancer Hospital & Institute, Fudan University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Air Force Military Medical University, China, Shanxi Dayi Hospital, First Affiliated Hospital Xi'an Jiaotong University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04320979
Brief Title
Postmastecomy Internal Mammary Nodal Irradiation for High-risk Breast Cancer Patients
Official Title
Postmastectomy Prophylactic Internal Mammary Nodal Irradiation for High-risk Patients With Non-metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast neoplasm, mastectomy, radiotherapy, internal mammary node

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
internal mammary nodal irradiation
Arm Type
Experimental
Arm Description
chest wall and supraclavicular nodal+-axillary plus internal mammary nodal irradiation
Arm Title
no-internal mammary nodal irradiation
Arm Type
Active Comparator
Arm Description
ipsilateral chest wall and supraclavicular +-axillary nodal irradiation
Intervention Type
Radiation
Intervention Name(s)
internal mammary nodal irradiation
Intervention Description
chest wall and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).
Intervention Type
Radiation
Intervention Name(s)
no internal mammary nodal irradiation
Intervention Description
chest wall and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).
Primary Outcome Measure Information:
Title
disease-free survival
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
overall survival
Description
the incidence of death due to any cause.
Time Frame
5 years
Title
cumulative internal mammary nodal recurrence
Description
ipsilateral internal mammary nodal relapse during follow up.
Time Frame
5 years
Title
cumulative locoregional recurrence
Description
ipsilateral chest wall, axilla, supraclavicular and internal mammary nodal relapse during follow up.
Time Frame
5 years
Title
distant metastasis
Description
the incidence of first relapse beyond locoregional region.
Time Frame
5 years
Title
contralateral non-invasive breast cancer or other malignant tumors
Description
the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment.
Time Frame
5 years
Title
major cardiovascular events
Description
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).
Time Frame
5 years
Title
incidence of adverse events
Description
graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0.
Time Frame
5 years
Title
quality of life
Description
questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-lian Wang, M.D
Phone
8610-87788803
Email
wangsl@cicams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ye-xiong Li, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
Phone
8610-87788803
Email
wangsl@cicams.ac.cn
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D

12. IPD Sharing Statement

Citations:
PubMed Identifier
34742270
Citation
Zhao XR, Fang H, Tang Y, Hu ZH, Jing H, Liang L, Yan XN, Song YW, Jin J, Liu YP, Chen B, Tang Y, Qi SN, Li N, Lu NN, Men K, Hu C, Zhang YH, Li YX, Wang SL. POstmastectomy radioThErapy in Node-posiTive breast cancer with or without Internal mAmmary nodaL irradiation (POTENTIAL): a study protocol for a multicenter prospective phase III randomized controlled trial. BMC Cancer. 2021 Nov 6;21(1):1185. doi: 10.1186/s12885-021-08852-y.
Results Reference
derived

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

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