Table 2.

Carboplatin-based chemotherapy in neoadjuvant treatment: randomized Phase II results

Phase II trials	n	Standard chemotherapy	Standard chemotherapy + carboplatin	Toxicity
GeparSixto52 TNBC subgroup Weekly paclitaxel and liposomal doxorubicin ×18 weeks + bevacizumab every 3 weeks ×6 cycles ± weekly carboplatin AUC 2×18 weeks	315	pCR: 36.9% (ypT0N0) 3-year EFS 76.1%	pCR: 53.2% (ypT0N0) 3-year EFS 85.8%	Increased with carboplatin (AUC 2) More grade 3/4 anemia More grade 3/4 neutropenia More grade 3/4 thrombopenia More grade 3/4 diarrhea Reduction of carboplatin AUC to 1.5 → reduced hematological events (from 82% to 70%) and nonhematological events (78% to 59%)
CALGB 40603, only TNBC53 Weekly paclitaxel ×12 weeks ± carboplatin AUC 6 every 3 weeks ×4 cycles/dose-dense anthracycline–cyclophosphamide ×4 cycles	443	pCR 41% (ypT0/TisN0) 3-year EFS 71.6%	pCR 54% (ypT0/TisN0) 3-year EFS 76.5%	Increased with carboplatin More grade 3/4 neutropenia More grade 3/4 thrombopenia
GEICAM/2006-0354 Epirubicin–cyclophosphamide every 3 weeks ×4 cycles/docetaxel every 3 weeks ×4 cycles ± carboplatin AUC 6 every 3 weeks ×4 cycles	94	pCR 35% (ypT0N0)	pCR 30% (ypT0N0)	No difference in grade 3/4 toxicity
I-SPY arm 155 Weekly paclitaxel ×12 weeks/dose-dense doxorubicin–cyclophosphamide ×4 cycles ± veliparib and carboplatin	62	pCR 26% (ypT0N0)	pCR 52% (ypT0N0)	More toxicity with carboplatin/veliparib ≥ Hematological grade 3 events: 26.4% versus 4.5%
Paclitaxel plus carboplatin versus paclitaxel plus epirubicin as neoadjuvant treatment in locally advanced TNBC51 Paclitaxel–carboplatin AUC 5 every 3 weeks ×4–6 cycles or epirubicin–paclitaxel every 3 weeks ×4–6 cycles	91	pCR: 14% (ypT0/TisN0) 4-year RFS 52.8%	pCR: 38.6% (ypT0/TisN0) 4-year RFS 71.1%	No difference in grade 3/4 toxicity

Abbreviations: AUC, area under curve; EFS, event-free survival; is, in situ; pCR, pathologic complete response; RFS, relapse-free survival; TNBC, triple-negative breast cancer.