However, four studies adequately powered to detect improvement in event-free survival in conjunction with a carboplatin-induced benefit in terms of pCR are underway, including the NRG-BR-003 trial in the U.S. and the BrighTNess study in China.
In addition, a study with an innovative post-neoadjuvant design for platinum-based therapy is underway. The ECOG-ACRIN 1131 study is a Phase III randomized postoperative trial of four rounds of carboplatin or cisplatin versus observation in patients with residual TNBC following an anthracycline-based neoadjuvant regimen. This strategy limits exposure to the toxicities of platinum-based compounds to those patients in need of additional therapy. The planned 558-patient trial is powered to detect a 33% improvement in event-free survival.