Trastuzumab deruxtecan
Monoclonal antibody targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 13 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (11) | US (FDA) | ENHERTU | — | 2021-01-15 – 2026-05-15 | fda.gov ↗ |
| Approved · conditional | EU (EMA) | Enhertu | — | 2021-01-18 | europa.eu ↗ |
| Approved | US (FDA) | ENHERTU | — | 2019-12-20 | fda.gov ↗ |
Trials 140 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials | ||||||
| Phase 1 | NCT07137416 | Oct 2026 → Jan 2028 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma +3 | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT07553390 | Oct 2026 → Mar 2036 expected | breast cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07454668 | Jun 2026 → Jul 2028 expected | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Baptist Health South Florida | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07015697 | Jul 2025 → Dec 2028 expected | — | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 1 | NCT06364410 | Feb 2025 → Jul 2027 expected | gastric carcinoma, gastroesophageal junction adenocarcinoma, high grade malignant neoplasm, metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT06331169 | Jul 2024 → Dec 2026 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 1 | NCT05774886 | May → Sep 2023 | female breast carcinoma, triple-negative breast carcinoma | Dana-Farber Cancer Institute | Withdrawn | No outcome recorded |
| Phase 1 | NCT05650879 | Mar 2023 → Jul 2026 overdue | HER2 positive breast carcinoma, lung cancer | Enliven Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05868226 | Feb 2023 → Dec 2028 expected | HER2 positive breast carcinoma, hormone receptor-positive breast cancer, metastatic malignant neoplasm, triple-negative breast carcinoma | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 1 | NCT05633979 | Feb 2023 → Dec 2030 expected | breast cancer | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05372614 | Oct 2022 → Sep 2025 | metastatic malignant neoplasm | National Cancer Institute (NCI) | Suspended | No outcome recorded |
| Phase 1 | NCT05274048 | Jun 2022 → Jun 2026 overdue | gastric cancer | Fox Chase Cancer Center | Recruiting | No outcome recorded |
| Phase 1 | NCT04704661 | Aug 2021 → Mar 2027 expected | HER2 positive breast carcinoma, colon carcinoma, endometrial carcinoma, female breast carcinoma +6 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04585958 | May 2021 → Dec 2026 expected | metastatic malignant neoplasm, serous adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1 | NCT04556773 | Dec 2020 → Aug 2023 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04294628 | Sep 2020 → Sep 2025 overdue | metastatic malignant neoplasm, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04042701 | Feb 2020 → Jul 2025 overdue | breast cancer, non-small cell lung carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03523572 | Aug 2018 → Jul 2021 | breast cancer, urothelial carcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03368196 | Apr → Sep 2018 | breast neoplasm, gastric adenocarcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03383692 | Jan → Sep 2018 | metastatic malignant neoplasm | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03366428 | Dec 2017 → Dec 2018 | breast cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02564900 | Sep 2015 → Feb 2019 | cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1/217 trials | ||||||
| Phase 1/2 | NCT07619521 | Sep → Oct 2026 expected | pancreatic ductal adenocarcinoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07701941 | Aug 2026 → Jan 2031 expected | hormone receptor-positive breast cancer | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07012031 | Jun 2026 → Jun 2027 expected | non-small cell lung carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07198724 | Nov 2025 → Jun 2028 expected | Her2-receptor negative breast cancer, female breast carcinoma | Kristina A. Fanucci | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06731803 | Mar 2025 → Dec 2027 expected | gastroesophageal adenocarcinoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06085755 | Sep 2024 → Dec 2025 overdue | gastric neoplasm | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06525298 | Sep 2024 → Sep 2027 expected | neoplasm | Eisbach Bio GmbH | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06328387 | Jan 2024 → Feb 2026 | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1/2 | NCT07529613 | Dec 2023 → Dec 2025 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center Hospital East | Completed | No outcome recorded |
| Phase 1/2 | NCT05824975 | May 2023 → Nov 2025 overdue | Her2-receptor negative breast cancer, colorectal cancer, cutaneous melanoma, hepatocellular carcinoma +3 | GI Innovation, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05417594 | Jun 2022 → Nov 2027 expected | high grade malignant neoplasm | AstraZeneca | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05091528 | Feb → Jul 2022 | HER2 positive breast carcinoma, non-small cell lung carcinoma | Silverback Therapeutics | Terminated | No outcome recorded |
| Phase 1/2 | NCT04616560 | Mar 2021 → Dec 2027 expected | desmoplastic small round cell tumor, kidney Wilms tumor, osteosarcoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04538742 | Dec 2020 → Jan 2025 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04644068 | Nov 2020 → May 2027 expected | biliary tract cancer, breast cancer, cervical cancer, colorectal cancer +8 | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03742102 | Dec 2018 → Nov 2024 overdue | triple-negative breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03424005 | Mar 2018 → Sep 2030 expected | breast cancer | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 274 trials | ||||||
| Phase 2 | NCT07126561 | Nov 2026 → Nov 2028 expected | carcinoma | University of Chicago | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07619365 | Aug 2026 → Aug 2030 expected | breast cancer | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07691489 | Aug 2026 → Jun 2029 expected | colon adenocarcinoma, rectum adenocarcinoma | Memorial Sloan Kettering Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07662473 | Jul 2026 → Dec 2027 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07527806 | May 2026 → May 2029 expected | breast cancer | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07497386 | Apr 2026 → Jun 2028 expected | breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07647016 | Apr 2026 → Dec 2027 expected | breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT07459673 | Mar 2026 → Mar 2030 expected | HER2 positive breast carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07340164 | Feb → Dec 2026 expected | ovarian carcinoma | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT07371585 | Feb 2026 → Aug 2029 expected | breast cancer | SOLTI Breast Cancer Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT07428044 | Feb 2026 → Feb 2027 expected | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07393425 | Feb 2026 → Sep 2027 expected | HER2 positive breast carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT07368543 | Jan 2026 → Jun 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07152782 | Nov 2025 → Nov 2027 expected | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07407465 | Oct 2025 → Oct 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT07151586 | Oct 2025 → Oct 2029 expected | metastatic malignant neoplasm, triple-negative breast carcinoma | UNICANCER | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07150208 | Sep 2025 → Sep 2027 expected | breast carcinoma by gene expression profile | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06680596 | Jul 2025 → Aug 2028 expected | breast carcinoma | UNICANCER | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT07069712 | Jul 2025 → Jan 2027 expected | gastroesophageal adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT07657130 | Jul 2025 → Jun 2026 overdue | female breast carcinoma | Liaoning Cancer Hospital & Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06486883 | Jun 2025 → Jan 2027 expected | hormone receptor-positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 2 | NCT06750484 | Jun 2025 → Dec 2028 expected | breast carcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06832202 | Apr 2025 → Jun 2027 expected | hormone receptor-positive breast cancer | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
| Phase 2 | NCT06311214 | Mar 2025 → Mar 2028 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT06610825 | Mar 2025 → Oct 2027 expected | castration-resistant prostate carcinoma, metastatic prostate carcinoma | Washington D.C. Veterans Affairs Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06797622 | Feb 2025 → Jan 2027 expected | breast cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06450314 | Jan 2025 → Dec 2027 expected | HER2 positive breast carcinoma | UNICANCER | Recruiting | No outcome recorded |
| Phase 2 | NCT06630130 | Jan 2025 → Oct 2028 expected | gastric cancer | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 2 | NCT06733233 | Jan 2025 → Jan 2028 expected | estrogen-receptor positive breast cancer | Guangzhou Women and Children's Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06533826 | Oct 2024 → Jan 2028 expected | Her2-receptor negative breast cancer | Ana C Garrido-Castro, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT06548178 | Sep 2024 → Sep 2025 overdue | HER2 positive breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06409390 | Aug 2024 → Apr 2027 expected | breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06439693 | Aug 2024 → Mar 2030 expected | HER2 positive breast carcinoma, estrogen-receptor positive breast cancer, female breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06172127 | Jul 2024 → Apr 2027 expected | HER2 positive breast carcinoma | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06250777 | Jul 2024 → Dec 2026 expected | non-small cell lung carcinoma | Yonsei University | Enrolling by invitation | No outcome recorded |
| Phase 2 | NCT06048718 | Jun 2024 → Nov 2026 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05982678 | May 2024 → Oct 2027 expected | HER2 positive breast carcinoma | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05965479 | Apr 2024 → Mar 2026 overdue | gastroesophageal adenocarcinoma | University of Southampton | Recruiting | No outcome recorded |
| Phase 2 | NCT06253650 | Mar 2024 → Mar 2027 expected | gastric cancer | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT06271837 | Feb 2024 → Nov 2025 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05704829 | Feb 2024 → Jun 2030 expected | HER2 positive breast carcinoma | West German Study Group | Recruiting | No outcome recorded |
| Phase 2 | NCT06088056 | Nov 2023 → Jun 2024 overdue | breast cancer, metastatic malignant neoplasm in the brain | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05900206 | Oct 2023 → Apr 2027 expected | breast cancer | Karolinska University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05710666 | Oct 2023 → Sep 2025 overdue | HER2 positive breast carcinoma | Cancer Trials Ireland | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06837792 | Oct 2023 → Oct 2026 expected | Her2-receptor negative breast cancer | Yonsei University | Recruiting | No outcome recorded |
| Phase 2 | NCT05744375 | Sep 2023 → Jul 2025 | breast cancer | Spanish Breast Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT06058988 | Sep 2023 → Sep 2027 expected | brain cancer, glioblastoma, neoplastic meningitis | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06145308 | Aug 2023 → Jul 2028 expected | salivary gland carcinoma | Peking Union Medical College | Recruiting | No outcome recorded |
| Phase 2 | NCT05953168 | Aug 2023 → Aug 2024 overdue | triple-negative breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05480384 | Jul 2023 → May 2025 overdue | HER2 positive breast carcinoma, esophageal adenocarcinoma, gastroesophageal cancer | Brown University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2026 overdue | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05795101 | May 2023 → Dec 2027 expected | HER2 positive breast carcinoma, inflammatory breast carcinoma | Filipa Lynce, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05408845 | Mar 2023 → Jul 2028 expected | major salivary gland carcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT05246514 | Jul 2022 → Nov 2024 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05097599 | Apr 2022 → Jun 2024 | cancer | Strata Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT05034887 | Jan 2022 → Mar 2028 expected | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | National Cancer Center Hospital East | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04989816 | Aug 2021 → Jun 2023 | gastroesophageal adenocarcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT04644237 | Mar 2021 → Dec 2022 | non-small cell lung carcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT04744831 | Mar 2021 → Nov 2022 | colorectal cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT04639219 | Dec 2020 → Jan 2023 overdue | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04539938 | Dec 2020 → Jul 2024 | HER2 positive breast carcinoma | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT04553770 | Oct 2020 → Dec 2026 expected | female breast carcinoma, hormone receptor-positive breast cancer, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04482309 | Aug 2020 → Mar 2027 expected | — | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04752059 | Jul 2020 → May 2023 | breast cancer | Medical University of Vienna | Completed | No outcome recorded |
| Phase 2 | NCT04379596 | Jun 2020 → Jun 2027 expected | gastric cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT04420598 | May 2020 → Sep 2021 | HER2 positive breast carcinoma, malignant leptomeningeal tumor, metastatic malignant neoplasm in the brain | MedSIR | Completed | No outcome recorded |
| Phase 2 | NCT04014075 | Nov 2019 → Nov 2021 | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT04132960 | Oct 2019 → Oct 2021 | breast neoplasm | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT03505710 | May 2018 → May 2021 | non-small cell lung carcinoma | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 2 | NCT03384940 | Feb 2018 → Aug 2019 | colorectal neoplasm | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT03334617 | Dec 2017 → Sep 2024 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03329690 | Nov 2017 → Nov 2019 | digestive system neoplasm | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 2 | NCT03248492 | Aug 2017 → Mar 2019 | breast cancer | Daiichi Sankyo | Terminated | No outcome recorded |
| Phase 2 | NCT02693535 | Mar 2016 → Dec 2027 expected | non-Hodgkin lymphoma, plasma cell myeloma | American Society of Clinical Oncology | Recruiting | No outcome recorded |
| Phase 321 trials | ||||||
| Phase 3 | NCT07683754 | Sep 2026 → Jul 2030 expected | HER2 positive breast carcinoma, female breast carcinoma, hormone receptor-positive breast cancer | Daiichi Sankyo | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06585969 | Jan 2026 | basal-like breast carcinoma, estrogen-receptor positive breast cancer, luminal B breast carcinoma | Danish Breast Cancer Cooperative Group | Withdrawn | No outcome recorded |
| Phase 3 | NCT06899126 | Oct 2025 → Apr 2030 expected | non-small cell lung carcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT07022483 | Sep 2025 → Mar 2032 expected | endometrial cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06643585 | Apr 2025 → Apr 2032 expected | breast cancer | University of Ulm | Recruiting | No outcome recorded |
| Phase 3 | NCT06989112 | Mar 2025 → Jan 2029 expected | endometrial cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06819007 | Mar 2025 → Nov 2028 expected | ovarian cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06764875 | Mar 2025 → Apr 2029 expected | gastroesophageal junction adenocarcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT06731478 | Feb 2025 → Jun 2028 expected | gastric cancer, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT06467357 | Aug 2024 → Jun 2028 expected | biliary tract cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 3 | NCT05950945 | Dec 2023 → Oct 2027 expected | breast cancer | Daiichi Sankyo | Recruiting | No outcome recorded |
| Phase 3 | NCT05048797 | Oct 2021 → Jun 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05113251 | Oct 2021 → Mar 2025 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04739761 | Jun 2021 → Feb 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04704934 | May 2021 → Aug 2026 overdue | gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04784715 | Apr 2021 → Jul 2026 overdue | HER2 positive breast carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04622319 | Dec 2020 → Jul 2025 overdue | HER2 positive breast carcinoma, invasive breast carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04494425 | Jul 2020 → Mar 2024 overdue | breast cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03734029 | Dec 2018 → Jan 2022 overdue | breast cancer | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03529110 | Aug 2018 → May 2021 overdue | breast cancer | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03523585 | Aug 2018 → Jun 2022 | breast cancer | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 45 trials | ||||||
| Phase 4 | NCT07162259 | Oct 2025 → Dec 2027 expected | breast cancer | Yan Xue | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06429761 | Jan 2025 → Oct 2026 expected | breast cancer | AstraZeneca | Recruiting | No outcome recorded |
| Phase 4 | NCT06245824 | Jan 2024 → Mar 2026 overdue | breast cancer | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06230055 | Jan 2024 → Jan 2026 overdue | Her2-receptor negative breast cancer, malignant leptomeningeal tumor | Fudan University | Recruiting | No outcome recorded |
| Phase 4 | NCT05376878 | Dec 2022 → Apr 2027 expected | invasive breast carcinoma, metastatic malignant neoplasm in the brain | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07281001 | Dec 2025 → May 2026 overdue | HER2 positive breast carcinoma | Blokhin's Russian Cancer Research Center | Recruiting | No outcome recorded |
Also used as a comparator or background therapy in 16 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07318389 Background | Jun 2026 → Nov 2027 expected | colorectal cancer | M.D. Anderson Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT07086768 Background | Jan 2026 → Aug 2027 expected | metastatic malignant neoplasm | Lei Zheng | Recruiting | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07157956 Background | Sep 2025 → Aug 2028 expected | neoplasm | Convalife (Shanghai) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06771622 Background | Mar 2025 → Jan 2028 expected | — | FBD Biologics Limited | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06324357 Background | Jun 2024 → Jan 2029 expected | breast cancer, colorectal cancer, esophageal adenocarcinoma, gastric adenocarcinoma +1 | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT07474558 Background | Sep 2026 → Jan 2030 expected | alopecia, metastatic neoplasm | Jules Bordet Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07678957 Comparator | Jul 2026 → Dec 2028 expected | breast cancer | Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07630103 Comparator | Jun 2026 → Jun 2031 expected | breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07416253 Comparator | Mar 2026 → Mar 2027 expected | breast cancer | Henan Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07394218 Background | Dec 2025 → Mar 2028 expected | Her2-receptor negative breast cancer | Fudan University | Recruiting | No outcome recorded |
| Phase 2 | NCT06102824 Comparator | Oct 2024 → Jun 2027 expected | Her2-receptor negative breast cancer | Guangdong Provincial People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04986579 Background | Oct 2021 → Jun 2028 expected | breast cancer, chemotherapy-induced alopecia | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07578116 Background | Mar 2027 → May 2032 expected | HER2 positive breast carcinoma, female breast carcinoma | SWOG Cancer Research Network | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07543536 Background | May 2026 → Apr 2029 expected | breast cancer | Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07060807 Comparator | Jul 2025 → Jul 2033 expected | breast neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07371910 Comparator | Jun 2024 → Mar 2031 expected | Her2-receptor negative breast cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Active not recruiting | No outcome recorded |
Press releases naming this drug 79 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | AstraZeneca | Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2026-06-29 | AstraZeneca | Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours astrazeneca.com ↗ |
| 2026-05-22 | AstraZeneca | Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours astrazeneca.com ↗ |
| 2026-05-15 | AstraZeneca | Enhertu approved in the US for two new indications for patients with HER2-positive early breast cancer astrazeneca.com ↗ |
| 2026-03-09 | AstraZeneca | Enhertu granted Priority Review in the US as post-neoadjuvant treatment for patients with HER2-positive early breast cancer astrazeneca.com ↗ |
| 2025-12-22 | AstraZeneca | Enhertu granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer astrazeneca.com ↗ |
| 2025-12-15 | AstraZeneca | Enhertu plus pertuzumab approved in the US as first new treatment in a decade for the 1st-line treatment of patients with HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2025-10-18 | AstraZeneca | Enhertu reduced the risk of disease recurrence or death by 53% vs. T-DM1 in patients with high-risk HER2-positive early breast cancer following neoadjuvant therapy in DESTINY-Breast05 Phase III trial astrazeneca.com ↗ |
| 2025-10-18 | AstraZeneca | Enhertu followed by THP before surgery resulted in a pathologic complete response in 67% of patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗ |
| 2025-09-29 | AstraZeneca | Enhertu demonstrated highly statistically significant and clinically meaningful improvement in invasive disease-free survival vs. T-DM1 in DESTINY-Breast05 Phase III trial in patients with high-risk early breast cancer following neoadjuvant therapy astrazeneca.com ↗ |
| 2025-09-24 | AstraZeneca | Enhertu plus pertuzumab granted Priority Review in the US as 1st-line treatment for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2025-06-02 | AstraZeneca | Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP as 1st-line therapy in patients with HER2-positive metastatic breast cancer in DESTINY-Breast09 Phase III trial astrazeneca.com ↗ |
| 2025-05-07 | AstraZeneca | Enhertu followed by THP before surgery showed statistically significant and clinically meaningful improvement in pathologic complete response in patients with high-risk HER2-positive early-stage breast cancer in DESTINY-Breast11 Phase III trial astrazeneca.com ↗ |
| 2025-04-21 | AstraZeneca | Enhertu plus pertuzumab demonstrated highly statistically significant and clinically meaningful improvement in progression-free survival vs. THP as 1st-line therapy for patients with HER2-positive metastatic breast cancer astrazeneca.com ↗ |
| 2025-04-04 | AstraZeneca | Enhertu approved in the EU as first HER2-directed therapy for patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy astrazeneca.com ↗ |
| 2025-02-28 | AstraZeneca | Enhertu recommended for approval in the EU by CHMP for patients with HER2-low or HER2-ultralow metastatic breast cancer following at least one endocrine therapy astrazeneca.com ↗ |
| 2025-01-31 | Roche Global Development | Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU roche.com ↗ |
| 2025-01-27 | AstraZeneca | Enhertu approved in the US as first HER2-directed therapy for patients with HER2-low or HER2-ultralow metastatic breast cancer following disease progression after one or more endocrine therapies astrazeneca.com ↗ |
| 2024-10-14 | AstraZeneca | Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic non-small cell lung cancer astrazeneca.com ↗ |
| 2024-10-01 | AstraZeneca | Enhertu granted Priority Review in the US for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy astrazeneca.com ↗ |
| 2024-09-13 | AstraZeneca | Enhertu showed substantial clinical activity in patients with HER2-positive metastatic breast cancer and brain metastases astrazeneca.com ↗ |
| 2024-08-13 | AstraZeneca | Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer astrazeneca.com ↗ |
| 2024-06-02 | AstraZeneca | Enhertu demonstrated a median progression-free survival of 13.2 months in HR-positive, HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy astrazeneca.com ↗ |
| 2024-04-29 | AstraZeneca | Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial astrazeneca.com ↗ |
| 2024-04-06 | AstraZeneca | Enhertu approved in the US as first tumour-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumours astrazeneca.com ↗ |
| 2024-01-29 | AstraZeneca | Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours astrazeneca.com ↗ |
| 2023-10-23 | AstraZeneca | Enhertu demonstrated clinically meaningful survival across multiple HER2-expressing advanced solid tumours in DESTINY-PanTumor02 Phase II trial astrazeneca.com ↗ |
| 2023-10-23 | AstraZeneca | Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer astrazeneca.com ↗ |
| 2022-10-04 | Roche Global Development | Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for ENHERTU roche.com ↗ |
| 2021-01-29 | Daiichi Sankyo | Datopotamab Deruxtecan and ENHERTU® Show Promising Early Clinical Activity in Patients with Advanced Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
| 2021-01-27 | Daiichi Sankyo | ENHERTU® Receives Prime Minister’s Award from the Japan Techno-Economics Society daiichisankyo.com ↗ |
| 2021-01-20 | Daiichi Sankyo | ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2021-01-18 | Daiichi Sankyo | ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer daiichisankyo.com ↗ |
| 2020-12-14 | Daiichi Sankyo | Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-12-10 | Daiichi Sankyo | Results from First Combination Trial of ENHERTU® and Immune Checkpoint Inhibitor in Patients with HER2 Expressing Metastatic Breast Cancer Presented at the 2020 San Antonio Breast Cancer Symposium daiichisankyo.com ↗ |
| 2020-12-10 | Daiichi Sankyo | ENHERTU® Continues to Demonstrate Durable Responses with New Data from DESTINY-Breast01 in HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-11-04 | Daiichi Sankyo | DESTINY-Breast05 Head-to-Head Phase 3 Trial of ENHERTU® Versus T-DM1 Initiated in Patients with HER2 Positive Early Breast Cancer at High Risk After Neo-adjuvant Therapy daiichisankyo.com ↗ |
| 2020-10-28 | Daiichi Sankyo | ENHERTU® Granted Priority Review in the U.S. for Treatment of HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗ |
| 2020-09-25 | Daiichi Sankyo | ENHERTU® Approved in Japan for the Treatment of Patients with HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗ |
| 2020-07-07 | Daiichi Sankyo | EMA Validates and Grants Accelerated Assessment for Trastuzumab Deruxtecan for the Treatment of HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-06-01 | Daiichi Sankyo | ENHERTU® Significantly Improved Tumor Response Rate and Overall Survival in HER2 Positive Metastatic Gastric Cancer in Pivotal Phase 2 DESTINY-Gastric01 Trial daiichisankyo.com ↗ |
| 2020-06-01 | Daiichi Sankyo | ENHERTU® Achieved a Tumor Response Rate of 45.3% in Patients with HER2 Positive Metastatic Colorectal Cancer in Phase 2 DESTINY-CRC01 Trial daiichisankyo.com ↗ |
| 2020-06-01 | Daiichi Sankyo | ENHERTU® Demonstrated Meaningful Clinical Activity in Patients with HER2 Mutant Non-Small Cell Lung Cancer in Interim Analysis of Phase 2 DESTINY-Lung01 Trial daiichisankyo.com ↗ |
| 2020-05-25 | Daiichi Sankyo | Daiichi Sankyo Launches ENHERTU® in Japan for Patients with HER2 Positive Unresectable or Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-05-22 | Daiichi Sankyo | ENHERTU® Granted Orphan Drug Designation in the U.S. for Gastric Cancer daiichisankyo.com ↗ |
| 2020-05-18 | Daiichi Sankyo | ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Mutant Metastatic Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
| 2020-05-11 | Daiichi Sankyo | ENHERTU® Granted Breakthrough Therapy Designation in the U.S. for HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗ |
| 2020-05-07 | Daiichi Sankyo | Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2 Positive Metastatic Gastric Cancer daiichisankyo.com ↗ |
| 2020-03-25 | Daiichi Sankyo | ENHERTU® Approved in Japan for Treatment of Patients with HER2 Positive Unresectable or Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2020-01-27 | Daiichi Sankyo | Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint daiichisankyo.com ↗ |
| 2020-01-07 | Daiichi Sankyo | ENHERTU® Now Available in U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens daiichisankyo.com ↗ |
| 2019-12-23 | Daiichi Sankyo | ENHERTU® Approved in the U.S. for HER2 Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2-Based Regimens daiichisankyo.com ↗ |
| 2019-12-12 | Daiichi Sankyo | DS-8201 ([Fam-] Trastuzumab Deruxtecan) Achieved A Tumor Response Rate of 60.9% in Pivotal Phase 2 HER2 Positive Metastatic Breast Cancer Trial daiichisankyo.com ↗ |
| 2019-10-17 | Daiichi Sankyo | [Fam-] Trastuzumab Deruxtecan (DS-8201) Granted FDA Priority Review for Treatment of Patients with HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2019-09-09 | Daiichi Sankyo | Daiichi Sankyo Advances [Fam-] Trastuzumab Deruxtecan (DS-8201) in Japan with Regulatory Submission in HER2 Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2019-05-08 | Daiichi Sankyo | Daiichi Sankyo Announces [Fam-] Trastuzumab Deruxtecan Demonstrated Clinically Meaningful Response in Patients with Refractory HER2 Positive Metastatic Breast Cancer, a Population with High Unmet Need daiichisankyo.com ↗ |
| 2019-03-29 | Daiichi Sankyo | Daiichi Sankyo Confirms Plans to Accelerate BLA Submission to U.S. FDA for [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Positive Metastatic Breast Cancer Post T-DM1 daiichisankyo.com ↗ |
| 2019-03-29 | Daiichi Sankyo | Daiichi Sankyo and AstraZeneca Announce Global Development and Commercialization Collaboration for Daiichi Sankyo’s HER2 Targeting Antibody Drug Conjugate [Fam-] Trastuzumab Deruxtecan (DS-8201) daiichisankyo.com ↗ |
| 2019-01-15 | Daiichi Sankyo | Daiichi Sankyo Initiates Pivotal Phase 3 Trial of [Fam-] Trastuzumab Deruxtecan (DS-8201) in HER2 Low Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2018-12-10 | Daiichi Sankyo | Daiichi Sankyo Presents Updated Phase 1 Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Low Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS) daiichisankyo.com ↗ |
| 2018-10-26 | Daiichi Sankyo | Daiichi Sankyo Announces Clinical Research Collaboration with Merck KGaA, Darmstadt, Germany and Pfizer to Evaluate [Fam-] Trastuzumab Deruxtecan (DS-8201) with Avelumab and a DNA Damage Response Inhibitor in Patients with HER2 Expressing and Mutated Solid Tumors daiichisankyo.com ↗ |
| 2018-10-22 | Daiichi Sankyo | Daiichi Sankyo Presents Updated Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Expressing Advanced Colorectal Cancer at 2018 European Society for Medical Oncology (ESMO) Congress daiichisankyo.com ↗ |
| 2018-09-26 | Daiichi Sankyo | Daiichi Sankyo Initiates Two Phase 3 Trials of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Positive Metastatic Breast Cancer including Head-to-Head Versus T-DM1 and Post-T-DM1 Study daiichisankyo.com ↗ |
| 2018-09-25 | Daiichi Sankyo | Daiichi Sankyo Presents Updated Results for [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Mutated or HER2 Expressing Non-Small Cell Lung Cancer at IASLC 19th World Conference on Lung Cancer daiichisankyo.com ↗ |
| 2018-09-21 | Daiichi Sankyo | Daiichi Sankyo Announces Clinical Research Collaboration to Evaluate DS-8201 in Combination with KEYTRUDA® (pembrolizumab) in HER2 Expressing Breast and HER2 Expressing or HER2 Mutant Lung Cancers daiichisankyo.com ↗ |
| 2018-06-01 | Daiichi Sankyo | Daiichi Sankyo Presents Long-Term Phase 1 Results of Antibody Drug Conjugate DS-8201 in Patients with HER2-Expressing Breast, Gastric and Other Solid Cancers at 2018 American Society of Clinical Oncology (ASCO) Annual Meeting daiichisankyo.com ↗ |
| 2018-05-31 | Daiichi Sankyo | Daiichi Sankyo Initiates Phase 2 Study of DS-8201 in Patients with Advanced HER2-Overexpressing or HER2-Mutated Non-Squamous Non-Small Cell Lung Cancer daiichisankyo.com ↗ |
| 2018-03-27 | Daiichi Sankyo | Daiichi Sankyo’s HER2-Targeting Antibody Drug Conjugate DS-8201 Receives SAKIGAKE Designation for Gastric Cancer from Japan MHLW daiichisankyo.com ↗ |
| 2018-03-08 | Daiichi Sankyo | Daiichi Sankyo Initiates Phase 2 Study of DS-8201 in Patients with HER2-Expressing Advanced Colorectal Cancer daiichisankyo.com ↗ |
| 2018-01-19 | Daiichi Sankyo | Daiichi Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Gastric Cancer at ASCO 2018 Gastrointestinal Cancers Symposium daiichisankyo.com ↗ |
| 2017-12-08 | Daiichi Sankyo | Daiichi Sankyo Presents Updated Data for DS-8201 in Patients with HER2-Expressing Breast Cancer at San Antonio Breast Cancer Symposium daiichisankyo.com ↗ |
| 2017-11-21 | Daiichi Sankyo | Daiichi Sankyo Initiates Pivotal Phase 2 Study of DS-8201 in Patients with HER2-Positive Advanced Gastric Cancer daiichisankyo.com ↗ |
| 2017-09-12 | Daiichi Sankyo | Daiichi Sankyo Presents New Data for DS-8201 in Multiple HER2-Expressing Solid Tumors at European Society for Medical Oncology (ESMO) 2017 Congress daiichisankyo.com ↗ |
| 2017-08-30 | Daiichi Sankyo | FDA Grants Breakthrough Therapy Designation to Daiichi Sankyo’s DS-8201 for HER2-Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2017-08-30 | Daiichi Sankyo | Daiichi Sankyo Initiates Pivotal Phase 2 Study of DS-8201 in Patients with HER2-Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2017-08-29 | Daiichi Sankyo | Bristol-Myers Squibb and Daiichi Sankyo Announce Research Collaboration to Evaluate Opdivo® (nivolumab) and DS-8201 in HER2-Expressing Breast and Bladder Cancers daiichisankyo.com ↗ |
| 2017-06-06 | Daiichi Sankyo | New Precision Medicine Data on DS-8201 in HER2-Expressing Breast Cancer Revealed at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting daiichisankyo.com ↗ |
| 2016-12-02 | Daiichi Sankyo | U.S. FDA Grants Fast Track Designation for HER2-Targeting Antibody Drug Conjugate DS-8201 for HER2-Positive Metastatic Breast Cancer daiichisankyo.com ↗ |
| 2016-10-11 | Daiichi Sankyo | Daiichi Sankyo Presents Late-Breaking Phase 1 Data for Novel Investigational HER2-Targeting Antibody Drug Conjugate DS-8201a in T-DM1 Pre-Treated Breast Cancer at the ESMO 2016 Congress daiichisankyo.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 175 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trastuzumab deruxtecan | “The treatment of metastatic breast cancer (mBC) has evolved significantly in the past several years with the approval of new targeted agents. Trastuzumab deruxtecan (T-DXd), an...” PMID 35642907 ↗ Aug 2022142“Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line...” NCT06450314 ↗ “The purpose of this study is find out whether the combination of trastuzumab deruxtecan (T-DXd) and cetuximab is an effective treatment for participants with metastatic and/or...” NCT07691489 ↗ “Participants will receive 6 cycles of a standard intravenous or oral chemotherapy regimen or an Antibody-Drug Conjugate (ADC), selected by the investigator from...” NCT07371910 ↗ “This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have...” NCT07281001 ↗ “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗ “BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 32469182 ↗ May 2020 “Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low...” NCT06733233 ↗ “Trastuzumab deruxtecan (DS-8201a) is a novel HER2-targeted antibody-drug conjugate with a humanised anti-HER2 antibody, cleavable peptide-based linker, and potent topoisomerase...” PMID 31047803 ↗ Apr 2019 “Trastuzumab deruxtecan (T-DXd) is approved in patients with HER2-positive advanced gastric or gastroesophageal adenocarcinoma after failure of at least one prior...” PMID 40200187 ↗ Apr 2025 “antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer” NCT07162259 ↗ “This study evaluated effects of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd, DS-8201a) on QT/QTc interval and its pharmacokinetics.” PMID 36164935 ↗ Oct 2022 “Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies.” PMID 38231777 ↗ Apr 2024 “Trastuzumab Deruxtecan Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for HER2 Low Gastric and Gastroesophageal Junction Adenocarcinoma” NCT07529613 ↗ “ADC therapy includes sacituzumab govitecan or trastuzumab deruxtecan administered intravenously according to standard dosing schedules.” NCT07394218 ↗ “This study will test DS-8201a (trastuzumab deruxtecan), a HER2-targeted antibody and topoisomerase I inhibitor conjugate.” NCT03368196 ↗ “Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management” NCT07371585 ↗ “The Efficacy and Safety of Trastuzumab Deruxtecan in Advanced or Metastatic NSCLC With HER2 Over Expression” NCT07662473 ↗ “For Hormone receptor (HR)+/HER2-low patients, anti-HER2 ADCs such as trastuzumab deruxtecan may be used.” NCT07657130 ↗ “Carboplatin + paclitaxel + pembrolizumab (combination), Trastuzumab deruxtecan” NCT05774886 ↗ “Trastuzumab deruxtecan (T-DXd) 5.4mg/kg intravenous infusion every 3 weeks.” NCT06837792 ↗ “Trastuzumab Deruxtecan (T-DXd, 5.4 mg/kg intravenously every 21 days)” NCT07527806 ↗ “distinct trastuzumab-deruxtecan (T-DXd) combination therapies.” NCT06731803 ↗ “Trastuzumab-deruxtecan (T-DXd) has shown promising activity” NCT05704829 ↗ “CVL006（B006 Injection）、DS-8201a（Trastuzumab deruxtecan）” NCT07157956 ↗ “with trastuzumab deruxtecan (T-DXd).” NCT06680596 ↗ “Trastuzumab Deruxtecan (T-DXd)” NCT06548178 ↗ |
| Known as | DS-8201 | “Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗8“BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 32469182 ↗ May 2020 “BACKGROUND: Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable...” PMID 31825192 ↗ Dec 2019 “The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with HER2-mutant NSCLC have not been investigated extensively.” PMID 34534430 ↗ Sep 2021 “Trastuzumab deruxtecan (DS-8201) in patients with HER2-expressing metastatic colorectal cancer (DESTINY-CRC01): a multicentre, open-label, phase 2 trial.” PMID 33961795 ↗ May 2021 “Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies.” PMID 38231777 ↗ Apr 2024 “DS8201(5.4mg/kg, d1, q3w, ivgtt)” NCT06230055 ↗ |
| Known as | DS-8201a | “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗14“Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low...” NCT06733233 ↗ “Trastuzumab deruxtecan (DS-8201a) is a novel HER2-targeted antibody-drug conjugate with a humanised anti-HER2 antibody, cleavable peptide-based linker, and potent topoisomerase...” PMID 31047803 ↗ Apr 2019 “A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors...” NCT04482309 ↗ “Trastuzumab deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC)” NCT04042701 ↗ “Trastuzumab deruxtecan (T-DXd, DS-8201a)” NCT06486883 ↗ |
| Known as | DS-8201a (T-DXd) | “DS-8201a (T-DXd)” NCT04639219 ↗ |
| Known as | DS-8201a (trastuzumab derextecan) | “DS-8201a (trastuzumab derextecan)” NCT05950945 ↗ |
| Known as | DS-8210 | “multicenter single-arm phase II open label trial of Trastuzumab Deruxtecan (Enhertu, DS-8210).” NCT07126561 ↗ |
| Known as | Enhertu | “Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗3“The investigational study drug, fam-trastuzumab deruxtecan-nxki (ENHERTU® ), consists of an antibody component, MAAL-9001, covalently conjugated via a maleimide tetrapeptide...” NCT07691489 ↗ “multicenter single-arm phase II open label trial of Trastuzumab Deruxtecan (Enhertu, DS-8210).” NCT07126561 ↗ |
| Known as | fam-trastuzumab deruxtecan-nxki | “PURPOSE: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic...” PMID 36780610 ↗ Feb 20238“Trastuzumab deruxtecan (T-DXd, fam-trastuzumab deruxtecan-nxki) is a novel HER2- targeting antibody-drug conjugate (ADC).” NCT07428044 ↗ |
| Known as | SHR-A1811 | “Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer” NCT07393425 ↗ |
| Known as | T-DX | “Trastuzumab-Deruxtecan (T-DX; DS-8201a) in HER2-positive Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases” NCT04752059 ↗ |
| Known as | T-DXd | “The treatment of metastatic breast cancer (mBC) has evolved significantly in the past several years with the approval of new targeted agents. Trastuzumab deruxtecan (T-DXd), an...” PMID 35642907 ↗ Aug 202257“Trastuzumab deruxtecan (T-DXd, DS-8201, Enhertu) is a novel antibody drug conjugate that is comprised of 3 components: a humanized anti-HER2 IgG1 monoclonal antibody with the...” NCT06250777 ↗ “This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate...” NCT07543536 ↗ “DESTINY-CRC01 (NCT03384940) was a multicentre, open-label, phase 2 study that investigated the safety and efficacy of trastuzumab deruxtecan (T-DXd) in patients with human...” PMID 39587050 ↗ Nov 2024 “This is a Phase II Study of HLX22 in Combination with Trastuzumab Deruxtecan (T-DXd) in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer...” NCT06832202 ↗ “This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast...” NCT06088056 ↗ “Trastuzumab deruxtecan (T-DXd) demonstrated strong and durable responses in patients with previously treated HER2 (ERBB2) mutant (HER2m) metastatic NSCLC (mNSCLC) in the...” PMID 40749900 ↗ Jul 2025 “A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With...” NCT07416253 ↗ “PURPOSE: The US Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (DS-8201a, T-DXd) for the treatment of adult patients with unresectable or metastatic...” PMID 36780610 ↗ Feb 2023 “Trastuzumab Deruxtecan(T-DXd) or Sacituzumab Govitecan (SG) combined with hydroxychloroquine(HCQ) in the treatment of advanced breast cancer in clinical practice has the...” NCT06328387 ↗ “Trastuzumab deruxtecan (DS-8201a, T-DXd) is a novel HER2-targeted antibody-drug coupling (ADC) approved by the FDA and NMPA for the treatment of HER2-positive and HER2-low...” NCT06733233 ↗ “Trastuzumab deruxtecan (T-DXd) is a human epidermal growth factor 2 (HER2)-directed antibody-drug conjugate approved in HER2-expressing breast and gastric cancers and...” PMID 37870536 ↗ Oct 2023 “The Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) in Advanced or Metastatic NSCLC With Human Epidermal Growth Factor Receptor2(HER2) Overexpression(OE)：A Single-arm,...” NCT07662473 ↗ “Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate approved for human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC) and gastroesophageal...” PMID 42208007 ↗ May 2026 “PURPOSE: Trastuzumab deruxtecan (T-DXd, formerly DS-8201a) is a novel human epidermal growth factor receptor 2 (HER2)-targeted antibody drug conjugate (ADC) with a...” PMID 32058843 ↗ Feb 2020 “PURPOSE: To investigate efficacy and safety of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2 (HER2)-low gastric or gastroesophageal junction (GEJ)...” PMID 36379002 ↗ Nov 2022 “Trastuzumab deruxtecan (T-DXd) is approved in patients with HER2-positive advanced gastric or gastroesophageal adenocarcinoma after failure of at least one prior...” PMID 40200187 ↗ Apr 2025 “Prior research that has shown that the antibody-drug conjugate trastuzumab deruxtecan (T-DXd) has outstanding activity and survival benefit in HER2-low breast cancers.” NCT06750484 ↗ “antibody-drug conjugates (ADCs) such as sacituzumab govitecan (SG) and trastuzumab deruxtecan (T-DXd) have demonstrated significant activity in HR+/HER2- breast cancer” NCT07162259 ↗ “Trastuzumab deruxtecan (T-DXd) is an HER2-directed antibody-drug-conjugate (ADC) with promising results in the metastatic setting for HER2-positive breast cancer.” PMID 38233810 ↗ Jan 2024 “Trastuzumab Deruxtecan (T-DXd) Plus Nivolumab Plus Capecitabine Plus Oxaliplatin for Patients With HER2-Low Gastric and Gastroesophageal Junction Adenocarcinoma” NCT07529613 ↗ “This study evaluated effects of the HER2-targeted antibody-drug conjugate trastuzumab deruxtecan (T-DXd, DS-8201a) on QT/QTc interval and its pharmacokinetics.” PMID 36164935 ↗ Oct 2022 “Trastuzumab deruxtecan (T-DXd) is an antibody drug conjugate with a topoisomerase I payload that targets the human epidermal growth factor receptor 2 (HER2).” PMID 37207306 ↗ May 2023 “Trastuzumab deruxtecan (T-DXd) is approved for human epidermal growth factor receptor 2 (HER2)-positive and HER2-low advanced breast cancer (ABC).” PMID 39255534 ↗ Sep 2024 “Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several HER2-expressing solid tumors in multiple studies.” PMID 38231777 ↗ Apr 2024 “Trastuzumab deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases” NCT04752059 ↗ “* Trastuzumab Deruxtecan (T-DXd): Administered at a dose of 5.4 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle.” NCT07647016 ↗ “Researchers wanted to learn if the drug trastuzumab deruxtecan (T-DXd) could help treat participants with HER2-mutant NSCLC.” PMID 39012221 ↗ Jul 2024 “Trastuzumab deruxtecan (T-DXd, fam-trastuzumab deruxtecan-nxki) is a novel HER2- targeting antibody-drug conjugate (ADC).” NCT07428044 ↗ “Forty-one evaluable patients will be treated with trastuzumab deruxtecan (T-DXd) 5.4 mg/kg IV every 3 weeks (± 3 days).” NCT05744375 ↗ “Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management” NCT07371585 ↗ “Trastuzumab deruxtecan (T-DXd) 5.4mg/kg intravenous infusion every 3 weeks.” NCT06837792 ↗ “when combined with the therapeutic agent Trastuzumab Deruxtecan (T-DXd).” NCT07454668 ↗ “Trastuzumab Deruxtecan (T-DXd, 5.4 mg/kg intravenously every 21 days)” NCT07527806 ↗ “Trastuzumab Deruxtecan(T-DXd) 5.4mg/kg IV on D1, Q3W for 3 cycles” NCT06630130 ↗ “distinct trastuzumab-deruxtecan (T-DXd) combination therapies.” NCT06731803 ↗ “Trastuzumab-deruxtecan (T-DXd) has shown promising activity” NCT05704829 ↗ “Trastuzumab deruxtecan (T-DXd) with pyrotinib” NCT06245824 ↗ “trastuzumab deruxtecan (T-DXd; 5.4 mg kg-1)” PMID 42259988 ↗ Jun 2026 “Trastuzumab Deruxtecan (T-DXd) monotherapy” NCT05034887 ↗ “Trastuzumab deruxtecan (T-DXd, DS-8201a)” NCT06486883 ↗ “fam-trastuzumab deruxtecan-nxki (T-DXd)” NCT07459673 ↗ “Fam-Trastuzumab Deruxtecan-Nxki (TDxD)” NCT05274048 ↗ “Fam-Trastuzumab Deruxtecan-Nxki (TDxD)” NCT02693535 ↗ “with trastuzumab deruxtecan (T-DXd).” NCT06680596 ↗ “Drug: Trastuzumab-Deruxtecan (T-DXd)” NCT06048718 ↗ “Drug: Trastuzumab Deruxtecan (T-DXd)” NCT07150208 ↗ “trastuzumab deruxtecan (T-DXd)” NCT05824975 ↗ “Trastuzumab Deruxtecan (T-DXd)” NCT07069712 ↗ “Trastuzumab-Deruxtecan (T-DXd)” NCT07407465 ↗ “Trastuzumab deruxtecan (T-DXd)” NCT06585969 ↗ “Trastuzumab deruxtecan (T-DXd)” NCT06797622 ↗ “trastuzumab deruxtecan (T-DXd)” NCT05953168 ↗ “trastuzumab deruxtecan (T-DXd)” NCT07151586 ↗ “Trastuzumab deruxtecan (T-DXd)” NCT07553390 ↗ “Trastuzumab Deruxtecan (T-DXd)” NCT05417594 ↗ “Trastuzumab Deruxtecan (T-DXd)” NCT06548178 ↗ |
| Known as | Trastzumab Deruxtecan | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07340164 ↗ |
| Action | Inhibit | “topoisomerase I inhibitor” NCT03368196 ↗ |
| Modality | Other / unclassified | “An antibody drug conjugate” NCT03368196 ↗ |
| Route | Intravenous | “The recommended doses for expansion of 5·4 mg/kg or 6·4 mg/kg trastuzumab deruxtecan were administered intravenously to patients once every 3 weeks until withdrawal of consent,...” PMID 31047803 ↗ Apr 2019 |
| Target | ERBB2 | “target the human epidermal growth factor 2 (HER2) receptor” PMID 35642907 ↗ Aug 2022 |