The purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.
This is a phase III, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (PCI) in advanced triple negative breast cancer who response to the first line chemotherapy. Compare the PCI group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-cancer 30 (EORTC-QLQ-C30) questionnaire score and function of central nervous measured by the The Europe organization for research and treatment of cancer, Quality of life Questionnaire-brain cancer 20 (EORTC-QLQ-BN20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
326
Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
brain metastasis-free survival
time from randomization to brain metastasis
Time frame: eight years
cumulative risk of brain metastases within 1 year
the percent of subjects occurring brain metastases with 1 year
Time frame: one year
progression-free survival
time from randomization to disease progression or death(upon which happen earlier)
Time frame: eight years
overall survival
time from randomization to death
Time frame: eight years
life quality score
quality of life measured by the EORTC-QLQ-C30 questionnaire score
Time frame: eight years
central nervous function score
function of central nervous measured by the EORTC-QLQ-BN20 questionnaire score
Time frame: eight years
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