Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.
First outcome measures (analysis) :at the time of surgery, Second outcome measures: 2019 August, 5 year Overall Survival, Disease free survival
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks
Asan Medical Center
Seoul, South Korea
pathologic complete response (pCR) rate
Rate of pCR (as defined by NSABP \[National Surgical Adjuvant Breast and Bowel Project\] criteria - absence of invasive disease in the breast \[ypT0\]) at the time of surgery.
Time frame: up to 36 weeks
Overall response rate (ORR) by radiologic evaluation
after completion of chemotherapy Overall objective clinical response rate = CR (complete response) + PR (partial response) rate, measured by US (or MRI) and assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: up to 36 weeks
Complete metabolic response (CMR) rate after 2 cycles of AC
after 2 cycles of AC
Time frame: up to 12 weeks
3 year disease free survival (3yr-DFS)
Time frame: 3 years
Rate of breast conservation
after surgery
Time frame: up to 36 weeks
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