Breast Cancer
Conditions
Keywords
breast neoplasm, mastectomy, radiotherapy, internal mammary node
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 or breast-conserving surgery.
Detailed description
Eligible patients are randomized into 2 groups: chest wall/whole breast and supraclavicular nodal +-axillary plus internal mammary nodal irradiation, and chest wall/whole breast 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. Breast cancer patients treated with breast-conserving surgery will receive tumor bed boost. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.
Interventions
RADIATIONinternal mammary nodal irradiation
chest wall/whole breast and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Patients treated with breast-conserving surgery will receive tumor bed boost. Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.
RADIATIONno internal mammary nodal irradiation
chest wall/whole breast and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions). Concurrent boost (60 Gy in 25 fractions over 5 weeks or 49.5 Gy in 15 fractions over 3 weeks) or sequential boost (10 Gy in 5 fractions over 1 week or 8.7 Gy in 3 fractions over 3 days) is optional.
Sponsors
Hebei Medical University Fourth Hospital
Shanghai Zhongshan Hospital
Zhejiang Cancer Hospital
Beijing Hospital
Liaoning Cancer Hospital & Institute
Jilin Provincial Tumor Hospital
Tangshan People's Hospital
The First Hospital of Jilin University
West China Hospital
Peking Union Medical College Hospital
Henan Cancer Hospital
Zhongnan Hospital
Peking University Cancer Hospital & Institute
Fudan University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
Air Force Military Medical University, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Chinese Academy of Medical Sciences, Fuwai Hospital
Lanzhou University First Hospital
Jiangsu Province Hospital of Traditional Chinese Medicine
Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group Performance Status Scale 0-2 * Histologically confirmed invasive breast cancer * Underwent total mastectomy/breast-conserving surgery 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | failure: relapse of ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal or distant metastasis or contralateral invasive breast cancer or death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| quality of life | 5 years | questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale |
| cumulative locoregional recurrence | 5 years | ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal relapse during follow up. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Translational Research | 5 year | Circulating blood markers in relation to efficacy and toxicity |
Countries
China
Outcome results
None listed