Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial

Table 2 Five parameters for selection of the nab-paclitaxel regimen for phase III evaluation

Efficacy and safety endpoint parameters
HR of PFS (nab-P + Gem/nab-P + Carbo)^a
Ratio of ORR^a
Percentage of patients who initiated cycle 6 while receiving doublet combination therapy
Percentage of patients with myelosuppression-related events^b
Percentage of patients who discontinued all study treatment due to AEs
= Rank sum

^aCarries twice the weight of the remaining three endpoints
^bPercentage of patients with myelosuppression-related events is the percentage of patients with any of the following events: grade 3/4 neutropenia, grade 3/4 thrombocytopenia, grade 3/4 anemia, febrile neutropenia AEs, grade 3/4 bleeding AEs, red blood cell transfusion, or platelet transfusion. Each patient will be counted only once in the total percentage
AE adverse event, Carbo carboplatin, Gem gemcitabine, HR hazard ratio, nab-P nab-paclitaxel, ORR overall response rate, PFS progression-free survival

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