A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide
therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week
intervals.
In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment
group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of
carboplatin (AUC=6) on the first day of every 21 days.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (DFS)
To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
up to 3 years
Yes
Byeong Woo Park, MD, PhD
Principal Investigator
Severance Hospital
Korea: Food and Drug Administration
Severance_BR_01
NCT01752686
March 2013
March 2018
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