The Phase I SGNLVA-001 trial is investigating LV’s safety and efficacy in patients with pretreated metastatic breast cancer regardless of LIV-1 expression.90 An arm of the adaptive I-SPY2 trial also compared LV with an anthracycline-based regimen versus paclitaxel with an anthracycline-based regimen in patients with high-risk stage II or III HER2-negative breast cancer as neoadjuvant therapy. This evidence concerns the gene ERBB2 and breast cancer.