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Therapy Name Trastuzumab deruxtecan
Synonyms
Therapy Description

Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) 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, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, and in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Trastuzumab deruxtecan Enhertu DS-8201|DS8201a|T-DXd|DS-8201|fam-trastuzumab deruxtecan-nxki|DS-8201a HER2 (ERBB2) Antibody 76 HER2 (ERBB2) Antibody-Drug Conjugate 33 Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) 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, in patients with ERBB2 (HER2)-low (IHC 1+ or IHC 2+/ISH -) breast cancer received prior chemotherapy, in patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received prior trastuzumab-based therapy, in patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations who have received prior systemic therapy, and in patients with ERBB2 (HER2)-positive (IHC 3+) solid tumors who have received prior systemic therapy (FDA.gov).

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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
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) Active, not recruiting USA | TUR | ROU | POL | NLD | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | ARG 11
NCT05900206 Phase II Carboplatin + Docetaxel + Pertuzumab + Trastuzumab Letrozole + Pertuzumab + Ribociclib + Trastuzumab Cyclophosphamide + Epirubicin Trastuzumab deruxtecan Carboplatin + Paclitaxel + Pertuzumab + Trastuzumab Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer (ARIADNE) Recruiting SWE 0
NCT06439693 Phase II Docetaxel + Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Trastuzumab deruxtecan Nab-paclitaxel + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab + Tucatinib Ado-trastuzumab emtansine + Tucatinib The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer Not yet recruiting USA 0
NCT04482309 Phase II Trastuzumab deruxtecan A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) Recruiting USA | POL | NLD | ITA | GBR | ESP | CZE | CAN | BRA | BEL | AUS 6
NCT03505710 Phase II Trastuzumab deruxtecan DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer (DESTINY-Lung01) Completed USA | NLD | FRA | ESP 1
NCT05982678 Phase II Trastuzumab deruxtecan Basket Study for Oligo-metastatic Breast Cancer (ANISE) Recruiting NLD 0
NCT05744375 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab (TRANSCENDER) Recruiting ESP 0
NCT05376878 FDA approved Trastuzumab Trastuzumab deruxtecan An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis Recruiting USA 0
NCT03384940 Phase II Trastuzumab deruxtecan DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01) Completed USA | ITA | GBR | ESP 1
NCT06533826 Phase II Trastuzumab deruxtecan Datopotamab deruxtecan TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd (TRADE DXd) Not yet 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 | SWE | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BEL | AUT 6
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 | TUR | POL | NLD | ITA | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUT 7
NCT04686305 Phase I MEDI5752 + Trastuzumab deruxtecan Trastuzumab deruxtecan Carboplatin + MEDI5752 + Trastuzumab deruxtecan Durvalumab + Pemetrexed Disodium + Trastuzumab deruxtecan Carboplatin + Durvalumab + Trastuzumab deruxtecan Cisplatin + Durvalumab + Trastuzumab deruxtecan Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC (DL03) Recruiting USA | TUR | POL | NLD | ITA | ISR | FRA | ESP | CAN | BEL | AUS 6
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) Active, not recruiting USA | SWE | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUT | AUS | ARG 10
NCT04644237 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02) Completed USA | NLD | ITA | FRA | ESP | CAN | AUS 3
NCT06048718 Phase II Trastuzumab deruxtecan T-DXd Therapy for HER2-low Breast Cancer Patients With Brain Metastases (TUXEDO-4) Recruiting ESP | AUT 0
NCT05704829 Phase II Trastuzumab deruxtecan NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer (ADAPTHER2-IV) Recruiting DEU 0
NCT04294628 Phase I Trastuzumab deruxtecan Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer Active, not recruiting USA 0
NCT02564900 Phase I Trastuzumab deruxtecan Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors Completed USA 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) Active, not recruiting USA | SWE | POL | NOR | NLD | ITA | IRL | GBR | FIN | ESP | DNK | DEU | CHE | CAN | BEL | AUS 2
NCT06409390 Phase I Fulvestrant + Ribociclib Trastuzumab deruxtecan Sacituzumab govitecan-hziy Capecitabine Abemaciclib + Fulvestrant Cyclophosphamide + Docetaxel + Sargramostim Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer Recruiting USA 0
NCT04420598 Phase II Trastuzumab deruxtecan DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease (DEBBRAH) Completed ESP 1
NCT04379596 Phase II Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + Pembrolizumab + Trastuzumab deruxtecan Capecitabine + Fluorouracil + MEDI5752 + Trastuzumab deruxtecan Capecitabine + Pembrolizumab + Trastuzumab + Tucatinib Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) (DG-03) Recruiting USA | POL | NLD | ITA | GBR | ESP | DEU | CAN | BRA 5
NCT03248492 Phase II Trastuzumab deruxtecan A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) Completed USA | ITA | GBR | FRA | ESP | CAN | BEL 2
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 | TUR | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | BRA | BEL | AUS 2
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 | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS 5
NCT06058988 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer Recruiting USA 0
NCT05097599 Phase II Binimetinib + Encorafenib Trastuzumab deruxtecan Enfortumab vedotin-ejfv Talazoparib Lorlatinib Strata PATH (Precision Indications for Approved Therapies) (Strata PATH) Active, not recruiting USA 0
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) Active, not recruiting USA | TUR | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS 4
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
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 Active, not recruiting USA | POL | ITA | ESP | DEU | CAN | BRA | BGR 10
NCT06680596 Phase II Trastuzumab deruxtecan Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy (SAFIR3LibHERty) Not yet recruiting FRA 0
NCT04014075 Phase II Trastuzumab deruxtecan DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) Completed USA | ITA | GBR | ESP | BEL 0
NCT04752059 Phase II Trastuzumab deruxtecan Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases (TUXEDO-1) Completed AUT 0
NCT05965479 Phase II Trastuzumab deruxtecan Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer (DECIPHER) Recruiting GBR 0
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) Active, not recruiting USA | TUR | SWE | ROU | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL | ARG 11
NCT06467357 Phase III Cisplatin + Durvalumab + Gemcitabine Trastuzumab deruxtecan AZD2936 + Trastuzumab deruxtecan Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer (DESTINY-BTC01) Recruiting USA | SVK | POL | NLD | ITA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS 9
NCT04616560 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma Suspended USA 0
NCT06172127 Phase II Pertuzumab/trastuzumab/hyaluronidase-zzxf Trastuzumab deruxtecan PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer (DEMETHER) Recruiting ESP 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) Active, not recruiting TUR | ROU | POL | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DEU | BRA | BEL | ARG 10
NCT04639219 Phase II Trastuzumab deruxtecan A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) Active, not recruiting USA | ITA | FRA | ESP | DNK | CAN | BEL 2
NCT05950945 Phase III Trastuzumab deruxtecan Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer Recruiting USA | NLD | ITA | ESP | BRA | BEL 1
NCT04744831 Phase II Trastuzumab deruxtecan Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) Completed USA | ITA | GBR | FRA | ESP | BEL | AUS 3


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