Table 5 Selected trials of antibody–drug conjugates recruiting patients with HR + /HER2− or HR + /HER2-low advanced breast cancers—updated (August 2023).
Clinicaltrials.gov identifier | Phase | Antibody–drug conjugate | Drug target | Treatment arms | Study population | Study status |
|---|---|---|---|---|---|---|
NCT04494425 (DESTINY-Breast06) | III | Trastuzumab deruxtecan | HER2 | Trastuzumab deruxtecan vs TPC (capecitabine, paclitaxel, nab-paclitaxel) | Advanced/metastatic HR+/HER2-low breast cancer with at least 2 prior ET or PD within 6 months of first-line ET + CDK4/6i but no prior CT | Active, not recruiting |
NCT04556773 (DESTINY-Breast08) | Ib | Trastuzumab deruxtecan | HER2 | Trastuzumab deruxtecan + capecitabine or durvalumab + paclitaxel or capivasertib or anastrozole or fulvestrant | Part 1: previously treated HER2-low advanced/metastatic breast cancer Part 2: HER2-low MBC previously untreated or only 1 prior line | Active, not recruiting |
NCT04042701 (KEYNOTE 797) | Ib | Trastuzumab deruxtecan | HER2 | Trastuzumab deruxtecan + pembrolizumab | Advanced/metastatic breast cancer, HER2-low with prior failed standard treatments or HER2+ with prior ado-trastuzumab emtansine | Recruiting |
NCT04699630 | II | Patritumab deruxtecan | HER3 | Patritumab deruxtecan | Advanced/metastatic breast cancer—includes HER2+, HR+/HER2-low and TNBC | Recruiting |
NCT04965766 (ICARUS-BREAST) | II | Patritumab deruxtecan | HER3 | Patritumab deruxtecan | Advanced/metastatic HER3 high, HR+/HER2− breast cancer resistant to ET + CDK4/6i | Recruiting |
NCT04639986 (EVER-132-002) | III | Sacituzumab govitecan | TROP2 | Sacituzumab govitecan vs TPC (capecitabine, eribulin, gemcitabine, vinorelbine) | Asian patients with HR+/HER2− MBC with ≥2 but ≤4 prior lines of CT | Active, not recruiting |
NCT04448886 | II | Sacituzumab govitecan | TROP2 | Sacituzumab govitecan +/− pembrolizumab | Advanced/metastatic HR+/HER2− breast cancer PD on/within 12 months of adjuvant ET or with ≥1 prior ET | Recruiting |
NCT05143229 (ASSET) | I | Sacituzumab govitecan | TROP2 | Sacituzumab govitecan + alpelisib | Previously treated HER2- locally recurrent/metastatic breast cancer | Recruiting |
NCT04647916 (SWOG 2007) | II | Sacituzumab govitecan | TROP2 | Sacituzumab govitecan | HER2- MBC with CNS progression | Recruiting |
NCT05104866 (TROPION-Breast01) | III | Datopotamab deruxtecan | TROP2 | Datopotamab deruxtecan vs TPC (capecitabine, eribulin, gemcitabine, vinorelbine) | Advanced/metastatic HR+/HER2− breast cancer with PD on ET and 1–2 lines of CT | Active, not recruiting |
