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. 2023 Sep 8;9:74. doi: 10.1038/s41523-023-00578-3

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

CDK4/6i cyclin-dependent kinase 4/6 inhibitor, CNS central nervous system, CT chemotherapy, ET endocrine therapy, MBC metastatic breast cancer, PD disease progression, TNBC triple-negative breast cancer, TPC treatment of physician’s choice.