Trastuzumab Deruxtecan
Information
- Drug Name
- Trastuzumab Deruxtecan
- Description
- Entry(CIViC)
- 1
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| stomach cancer |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 31047804 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In a phase 1 trial, patients with HER2-positive ga... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03523585 | Active, not recruiting | Phase 3 | DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] | August 1, 2018 | May 1, 2025 |
| NCT04494425 | Active, not recruiting | Phase 3 | Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer | July 24, 2020 | June 19, 2026 |
| NCT04538742 | Active, not recruiting | Phase 1/Phase 2 | A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer | December 28, 2020 | January 31, 2025 |
| NCT05594082 | Active, not recruiting | Real-world Effectiveness and Safety Study of T-Dxd in Chinese Metastatic Breast Cancer | November 1, 2021 | July 1, 2024 | |
| NCT04539938 | Active, not recruiting | Phase 2 | A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer | December 1, 2020 | October 31, 2025 |
| NCT04556773 | Active, not recruiting | Phase 1 | A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer | December 17, 2020 | November 28, 2025 |
| NCT03334617 | Active, not recruiting | Phase 2 | Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy | December 18, 2017 | September 4, 2024 |
| NCT04639219 | Active, not recruiting | Phase 2 | A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations | December 30, 2020 | July 14, 2026 |
| NCT04644237 | Active, not recruiting | Phase 2 | Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) | March 19, 2021 | August 31, 2024 |
| NCT04294628 | Active, not recruiting | Phase 1 | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | September 1, 2020 | December 31, 2025 |
| NCT04784715 | Active, not recruiting | Phase 3 | Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | April 26, 2021 | December 30, 2029 |
| NCT06231693 | Active, not recruiting | Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil | December 4, 2023 | May 27, 2024 | |
| NCT05113251 | Active, not recruiting | Phase 3 | Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer | October 25, 2021 | April 30, 2027 |
| NCT05246514 | Active, not recruiting | Phase 2 | A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC | July 13, 2022 | June 24, 2024 |
| NCT03505710 | Completed | Phase 2 | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer | May 21, 2018 | April 17, 2024 |
| NCT04014075 | Completed | Phase 2 | DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02) | November 26, 2019 | February 13, 2024 |
| NCT05458401 | Completed | EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan | November 11, 2022 | December 1, 2023 | |
| NCT04752059 | Completed | Phase 2 | Phase II Study of T-DX in HER2-positive Breast Cancer Brain Metastases | July 28, 2020 | May 1, 2023 |
| NCT04989816 | Completed | Phase 2 | Study of T-DXd Monotherapy in Patients With HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens | August 20, 2021 | February 28, 2024 |
| NCT04420598 | Completed | Phase 2 | DS-8201a for trEatment of aBc, BRain Mets, And Her2[+] Disease | May 25, 2020 | April 4, 2023 |
| NCT04739761 | Completed | Phase 3 | A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer | June 22, 2021 | February 8, 2024 |
| NCT06364410 | Not yet recruiting | Phase 1 | Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors | August 30, 2024 | March 31, 2026 |
| NCT06439693 | Not yet recruiting | Phase 2 | The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer | November 2024 | March 30, 2033 |
| NCT06311214 | Not yet recruiting | Phase 2 | Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) | June 21, 2024 | October 31, 2024 |
| NCT05953168 | Not yet recruiting | Phase 2 | T-DXd in the First-Line Treatment of Locally Advanced or Metastatic TNBC-LAR HER2-low Patients | August 2023 | August 2026 |
| NCT06085755 | Not yet recruiting | Phase 1/Phase 2 | Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer | June 2024 | December 2026 |
| NCT06172127 | Not yet recruiting | Phase 2 | PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer | May 2024 | May 2029 |
| NCT05704829 | Not yet recruiting | Phase 2 | NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer | December 2023 | June 2028 |
| NCT06331169 | Not yet recruiting | Phase 1 | Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer | April 1, 2024 | June 30, 2027 |
| NCT06250777 | Not yet recruiting | Phase 2 | Efficacy and Safety of T-DXd in HER2-mutant Advanced Lung Cancer Patients With Asymptomatic Brain Metastases | February 2024 | April 2026 |
| NCT06429761 | Not yet recruiting | Phase 4 | A PROSPECTIVE, MULTI-CENTER, PHASE 4 STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN | September 30, 2024 | April 30, 2026 |
| NCT05845450 | Recruiting | Phase 2 | Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) | May 11, 2023 | May 2028 |
| NCT03424005 | Recruiting | Phase 1/Phase 2 | A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer | April 2, 2018 | May 3, 2026 |
| NCT03742102 | Recruiting | Phase 1/Phase 2 | A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer | December 21, 2018 | November 14, 2024 |
| NCT04379596 | Recruiting | Phase 2 | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03) | June 3, 2020 | July 30, 2026 |
| NCT04482309 | Recruiting | Phase 2 | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors | August 18, 2020 | July 30, 2027 |
| NCT04553770 | Recruiting | Phase 2 | Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer | October 9, 2020 | September 30, 2025 |
| NCT04704661 | Recruiting | Phase 1 | Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Patients With Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial | August 9, 2021 | March 31, 2026 |
| NCT04704934 | Recruiting | Phase 3 | 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) | May 21, 2021 | February 1, 2026 |
| NCT04986579 | Recruiting | Phase 2 | Scalp Cooling in MBC | October 7, 2021 | June 1, 2026 |
| NCT05048797 | Recruiting | Phase 3 | 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 | October 28, 2021 | March 29, 2027 |
| NCT05372614 | Recruiting | Phase 1 | Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene | October 5, 2022 | June 17, 2024 |
| NCT05376878 | Recruiting | Phase 4 | An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis | December 21, 2022 | February 25, 2026 |
| NCT05480384 | Recruiting | Phase 2 | Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction | July 14, 2023 | January 2027 |
| NCT05633979 | Recruiting | Phase 1 | Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer | February 9, 2023 | December 31, 2032 |
| NCT05744375 | Recruiting | Phase 2 | Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab | September 28, 2023 | March 1, 2029 |
| NCT05795101 | Recruiting | Phase 2 | TRUDI: TDXD+Durva in HER2+/Low IBC | May 4, 2023 | December 1, 2032 |
| NCT05900206 | Recruiting | Phase 2 | Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer | October 26, 2023 | April 30, 2032 |
| NCT05945732 | Recruiting | DESTINY Breast Respond HER2-low Europe | October 24, 2023 | September 1, 2028 | |
| NCT05950945 | Recruiting | Phase 3 | Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer | December 30, 2023 | October 1, 2027 |
| NCT05965479 | Recruiting | Phase 2 | Developing ctDNA Guided Adjuvant Therapy for Gastrooesophageal Cancer | April 10, 2024 | April 30, 2028 |
| NCT05982678 | Recruiting | Phase 2 | Basket Study for Oligo-metastatic Breast Cancer | May 2, 2024 | October 1, 2034 |
| NCT05993234 | Recruiting | A Study of Trastuzumab DeRuxtecan for Patients With Advanced HER2-pOsitive GaStric or GastroesoPhageal Junction AdEnocarcinoma Who Have Received a PrIor Trastuzumab-based Regimen Accompanied by a Disease RegistrY of Patients Treated With Conventional Therapies (PROSPERITY) | December 5, 2023 | September 1, 2027 | |
| NCT06058988 | Recruiting | Phase 2 | Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer | September 22, 2023 | September 22, 2027 |
| NCT06102824 | Recruiting | Phase 2 | Organoid-based Functional Precision Therapy for Advanced Breast Cancer | January 20, 2024 | June 30, 2028 |
| NCT06210776 | Recruiting | A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH) | January 15, 2024 | March 1, 2028 | |
| NCT06271837 | Recruiting | Phase 2 | A Study of T-DXd in Patients With Selected HER2-overexpressing Tumors | February 18, 2024 | April 17, 2026 |
| NCT06324357 | Recruiting | Phase 1/Phase 2 | Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread | May 23, 2024 | August 21, 2028 |
| NCT06328387 | Recruiting | Phase 1/Phase 2 | HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer | January 29, 2024 | March 1, 2026 |
| NCT06386263 | Recruiting | HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada | April 22, 2024 | April 4, 2025 | |
| NCT06409390 | Recruiting | Early Phase 1 | Sequential Therapies Modeled on Evolutionary Dynamics for Breast Cancer | April 26, 2024 | April 2027 |
| NCT04585958 | Suspended | Phase 1 | Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Endometrial Cancer | May 21, 2021 | June 30, 2024 |
| NCT04616560 | Suspended | Phase 2 | Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma | March 8, 2021 | March 31, 2025 |
| NCT05091528 | Terminated | Phase 1/Phase 2 | A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers | February 8, 2022 | July 7, 2022 |
| NCT03523572 | Unknown status | Phase 1 | Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer | June 20, 2018 | July 2022 |