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Therapy Name | Trastuzumab deruxtecan |
Synonyms | |
Therapy Description |
DS-8201a is an antibody-drug conjugate comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Trastuzumab deruxtecan | Enhertu | DS-8201|DS8201a|T-DXd|DS-8201fam-trastuzumab deruxtecan-nxki | HER2 (ERBB2) Antibody 57 | Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate comprising an anti-ERBB2 (HER2) antibody linked to a derivative of the topoisomerase inhibitor DX-8951, which delivers the cytotoxic agent to ERBB2 (HER2)-expressing tumor cells, potentially resulting in decreased growth of tumors, including tumors with low ERBB2 (HER2) expression (PMID: 27026201). Enhertu (fam-trastuzumab deruxtecan-nxki) is FDA approved for use in patients with ERBB2 (HER2)-positive breast cancer who have received two or more anti-HER2 therapies previously, and in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based therapy (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT04494425 | Phase III | Capecitabine Nab-paclitaxel Trastuzumab deruxtecan Paclitaxel | Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer (DB-06) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 20 |
NCT04784715 | Phase III | Pertuzumab + Trastuzumab deruxtecan Docetaxel + Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Trastuzumab deruxtecan | Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 21 |
NCT05048797 | Phase III | Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Trastuzumab deruxtecan | A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 12 |
NCT04538742 | Phase Ib/II | Durvalumab + Trastuzumab deruxtecan Pertuzumab + Trastuzumab deruxtecan Durvalumab + Paclitaxel + Trastuzumab deruxtecan Paclitaxel + Trastuzumab deruxtecan Trastuzumab deruxtecan | A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | 9 |
NCT03505710 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer | Active, not recruiting | USA | FRA | ESP | 2 |
NCT03248492 | Phase II | Trastuzumab deruxtecan | A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | BEL | 3 |
NCT03384940 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) | Completed | USA | ITA | ESP | 2 |
NCT04752059 | Phase II | Trastuzumab deruxtecan | Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases (TUXEDO-1) | Recruiting | AUT | 0 |
NCT04420598 | Phase II | Trastuzumab deruxtecan | DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (DEBBRAH) | Completed | ESP | 1 |
NCT03529110 | Phase III | Trastuzumab deruxtecan Ado-trastuzumab emtansine | DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 8 |
NCT05097599 | Phase II | Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib | Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) | Recruiting | USA | 0 |
NCT04704934 | Phase III | Paclitaxel + Ramucirumab Trastuzumab deruxtecan | Trastuzumab Deruxtecan for Subjects With HER2-Positive Gastric Cancer or Gastro-Esophageal Junction Adenocarcinoma After Progression on or After a Trastuzumab-Containing Regimen (DESTINY-Gastric04) | Recruiting | ITA | FRA | ESP | BEL | 14 |
NCT04553770 | Phase II | Trastuzumab deruxtecan Anastrozole + Trastuzumab deruxtecan | Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer | Recruiting | USA | 0 |
NCT04639219 | Phase II | Trastuzumab deruxtecan | A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) | Recruiting | USA | ITA | FRA | ESP | CAN | BEL | 3 |
NCT04379596 | Phase II | Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03) (DG-03) | Recruiting | USA | ITA | ESP | DEU | CAN | 9 |
NCT04482309 | Phase II | Trastuzumab deruxtecan | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) | Recruiting | USA | ITA | ESP | CAN | BEL | 11 |
NCT04622319 | Phase III | Trastuzumab deruxtecan Ado-trastuzumab emtansine | A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 24 |
NCT03523585 | Phase III | Trastuzumab deruxtecan Capecitabine + Lapatinib Capecitabine + Trastuzumab | DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] | Active, not recruiting | USA | ITA | FRA | ESP | DEU | BEL | 9 |
NCT04644237 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) | Active, not recruiting | USA | ITA | FRA | ESP | CAN | 5 |
NCT04616560 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma | Suspended | USA | 0 |
NCT02564900 | Phase I | Trastuzumab deruxtecan | Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors | Active, not recruiting | USA | 1 |
NCT04744831 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) | Active, not recruiting | USA | ITA | FRA | ESP | BEL | 5 |
NCT04014075 | Phase II | Trastuzumab deruxtecan | DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) | Active, not recruiting | USA | ITA | ESP | BEL | 1 |
NCT04739761 | Phase III | Trastuzumab deruxtecan | A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer (DESTINY-B12) | Recruiting | USA | ITA | ESP | DEU | CAN | BEL | 13 |
NCT05113251 | Phase III | Paclitaxel + Pertuzumab + Trastuzumab + Trastuzumab deruxtecan Trastuzumab deruxtecan Cyclophosphamide + Doxorubicin + Paclitaxel + Pertuzumab + Trastuzumab | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer | Recruiting | USA | ITA | ESP | DEU | CAN | AUT | 13 |
NCT04294628 | Phase I | Trastuzumab deruxtecan | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | Recruiting | USA | 0 |
NCT03734029 | Phase III | Trastuzumab deruxtecan Nab-paclitaxel Capecitabine Paclitaxel Gemcitabine Eribulin | Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 12 |