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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,400
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.
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.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
disease-free survival
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.
Time frame: 5 years
overall survival
the incidence of death due to any cause.
Time frame: 5 years
cumulative internal mammary nodal recurrence
ipsilateral internal mammary nodal relapse during follow up.
Time frame: 5 years
cumulative locoregional recurrence
ipsilateral chest wall/breast, axilla, supraclavicular and internal mammary nodal relapse during follow up.
Time frame: 5 years
distant metastasis
the incidence of first relapse beyond locoregional region.
Time frame: 5 years
contralateral non-invasive breast cancer or other malignant tumors
the incidence of contralateral invasive breast cancer or other malignant tumors developed after enrollment.
Time frame: 5 years
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).
Time frame: 5 years
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incidence of adverse events
graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 3.0.
Time frame: 5 years
quality of life
questionaire analysis with European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-BR23 scale
Time frame: 5 years