Clinical trial NCT04320979: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast neoplasm
mastectomy
radiotherapy
internal mammary node
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Hebei Medical University Fourth Hospital
name: Shanghai Zhongshan Hospital
name: Zhejiang Cancer Hospital
name: Beijing Hospital
name: Liaoning Cancer Hospital & Institute
name: Jilin Provincial Tumor Hospital
name: Shanxi Province Cancer Hospital
name: Tangshan People's Hospital
name: China-Japan Union Hospital, Jilin University
name: The First Hospital of Jilin University
name: West China Hospital
name: Peking Union Medical College Hospital
name: Anyang Tumor Hospital
name: Guizhou people's Hospital
name: Henan Cancer Hospital
name: Wuhan University
name: Peking University Cancer Hospital & Institute
name: Fudan University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: Air Force Military Medical University, China
name: Shanxi Dayi Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Chinese Academy of Medical Sciences, Fuwai Hospital
First posted: 2020-03-25
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: disease-free survival
timeFrame: 5 years
Secondary outcomes:
measure: overall survival
timeFrame: 5 years
measure: cumulative internal mammary nodal recurrence
timeFrame: 5 years
measure: cumulative locoregional recurrence
timeFrame: 5 years
measure: distant metastasis
timeFrame: 5 years
measure: contralateral non-invasive breast cancer or other malignant tumors
timeFrame: 5 years
measure: major cardiovascular events
timeFrame: 5 years
measure: incidence of adverse events
timeFrame: 5 years
measure: quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shu-lian Wang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Ye-xiong Li, M.D
role: STUDY_CHAIR
References:
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.