Most of these limitations will be overcome with the translational analysis of the ongoing SOLTI-2103 VALENTINE trial (NCT05569811), a parallel, non-comparative, three-arm, randomized open-label, multicenter study in 120 women or men with primary operable HR+/HER2- breast cancer with Ki67 ≥ 20% and/or high genomic risk (defined by gene signature) which was designed following the results of the SOLTI-1805 TOT-HER3 trial. Here, ERBB2 is linked to breast carcinoma.