This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer. Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
878
Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens. * Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles * Paclitaxel (80 mg/m2) IV weekly for 12 doses
Chungbuk university hospital
Cheonju, Chungchung Do, South Korea
National Cancer Center
Goyang, Gyeonggido, South Korea
5-year event-free survival (EFS)
time from Cycle1 Day1 to the occurrence of the following events : loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy
Time frame: 5 year
overall survival
Time from C1D1 until death from any cause
Time frame: 5 year
Distant recurrence free survival
Time from C1D1 until distant recurrence
Time frame: 5 year
loco-regional recurrence free survival
Time from C1D1 until locoregional recurrence
Time frame: 5 year
pathologic complete response rate
no evidence of invasive carcinoma in both breast and axillary lymph nodes, regardless of ductal carcinoma in situ (ypT0isN0)
Time frame: 5 year
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National Health Insurance Service Ilsan Hospital
Ilsan, Gyeonggido, South Korea
Bundang Cha Hospital
Seongnam, Gyeonggido, South Korea
Ajou universwity Medical Center
Suwon, Gyeonggido, South Korea
Soonchunhyang university Cheonan hospital
Cheonan, Gyungkido, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Seoul national university Bundang Hospital
Seongnam, South Korea
...and 11 more locations