This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls
Cyclophosphamide 600mg/m2 IV, q21d\*4cycls
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
Beijing, Beijing Municipality, China
RECRUITINGRFS
RFS defined as the time from randomization to the first recurrence event or death through the end of study
Time frame: median 5 years
OS
OS defined as the time from randomization to all-cause death through the end of study
Time frame: median 5 years
Percentage of patients with adverse events
To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0
Time frame: 2-3 years
Changes in patient-reported quality of life
To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30
Time frame: 2-3 years
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