Trastuzumab emtansine
Other / unclassified targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | KADCYLA | — | 2019-05-03 – 2025-05-14 | fda.gov ↗ |
| Approved | EU (EMA) | Kadcyla | — | 2013-11-15 | europa.eu ↗ |
| Approved | US (FDA) | KADCYLA | — | 2013-02-22 | fda.gov ↗ |
Trials 98 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05238831 | Jan 2023 → May 2026 | female breast carcinoma, ovarian carcinoma, pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |
| Phase 118 trials | ||||||
| Phase 1 | NCT05650879 | Mar 2023 → Jul 2026 overdue | HER2 positive breast carcinoma, lung cancer | Enliven Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04296942 | May → Oct 2021 | HER2 positive breast carcinoma, triple-negative breast carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT03364348 | Oct 2017 → Feb 2021 | HER2 positive breast carcinoma | George W. Sledge Jr. | Completed | No outcome recorded |
| Phase 1 | NCT03153163 | Jun 2017 → Sep 2018 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03032107 | Feb 2017 → Oct 2020 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT02605915 | Dec 2015 → Nov 2019 | HER2 positive breast carcinoma, female breast carcinoma, triple-negative breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02562378 | Oct 2015 → Dec 2018 | breast cancer | MedSIR | Completed | No outcome recorded |
| Phase 1 | NCT02390427 | Apr 2015 → Dec 2022 | breast carcinoma, metastatic neoplasm | Otto Metzger, MD | Completed | No outcome recorded |
| Phase 1 | NCT01816035 | Jun 2014 → Dec 2016 | HER2 positive breast carcinoma | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT02038010 | May 2014 → Apr 2015 | HER2 positive breast carcinoma | Northwestern University | Completed | No outcome recorded |
| Phase 1 | NCT01983501 | Feb 2014 → Oct 2017 | HER2 positive breast carcinoma | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02135159 | Feb 2014 → Feb 2017 | HER2 positive breast carcinoma | Institut du Cancer de Montpellier - Val d'Aurelle | Completed | No outcome recorded |
| Phase 1 | NCT01976169 | Jan 2014 → May 2021 | breast cancer | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02073916 | Oct 2013 → Dec 2018 | breast cancer | Jenny C. Chang, MD | Completed | No outcome recorded |
| Phase 1 | NCT01513083 | Feb 2012 → Sep 2014 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT00928330 | Jul 2009 → Jan 2014 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00932373 | Apr 2006 → Jun 2009 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT05081609 | Jan 2022 → Aug 2027 expected | HER2 positive breast carcinoma, cervical carcinoma, melanoma, metastatic neoplasm +2 | Ascendis Pharma A/S | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04486352 | Oct 2021 → Oct 2026 expected | endometrial cancer | Alliance Foundation Trials, LLC. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03709082 | Oct 2018 → Mar 2020 | HER2 positive breast carcinoma | University of Kansas Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02658084 | Apr 2017 → Oct 2018 | breast cancer | University of Miami | Terminated | No outcome recorded |
| Phase 1/2 | NCT02657343 | Mar 2016 → Aug 2020 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT02318901 | Oct 2014 → Aug 2018 | breast cancer, cancer of unknown primary site, colorectal cancer, esophageal cancer +1 | Western Regional Medical Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT02236000 | Aug 2014 → Dec 2020 | breast cancer | NSABP Foundation Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT00951665 | Aug 2009 → Feb 2012 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT00934856 | Jul 2009 → Oct 2013 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/2 | NCT00875979 | May 2009 → Aug 2011 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 248 trials | ||||||
| Phase 2 | NCT06595563 | Jun 2026 → Mar 2028 expected | HER2 positive breast carcinoma | Jules Bordet Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04419181 | Aug 2025 → Jun 2026 | HER2 positive breast carcinoma | University of Rochester | Withdrawn | No outcome recorded |
| Phase 2 | NCT06348134 | Mar 2025 → Jul 2034 expected | HER2 positive breast carcinoma, Her2-receptor negative breast cancer, female breast carcinoma | University of Chicago | Recruiting | No outcome recorded |
| Phase 2 | NCT06450314 | Jan 2025 → Dec 2027 expected | HER2 positive breast carcinoma | UNICANCER | 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 | NCT06125834 | Jun 2023 → Apr 2025 | breast cancer | The First Affiliated Hospital with Nanjing Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT05673928 | May 2023 → Mar 2027 expected | metastatic malignant neoplasm in the brain | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT05408845 | Mar 2023 → Jul 2028 expected | major salivary gland carcinoma | NRG Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT04675827 | Jan 2022 → Nov 2024 | HER2 positive breast carcinoma, estrogen-receptor negative breast cancer, progesterone-receptor negative breast cancer | Jules Bordet Institute | Terminated | No outcome recorded |
| Phase 2 | NCT04931342 | Oct 2021 → Feb 2028 expected | ovarian cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04733118 | Aug 2021 → Mar 2027 expected | breast cancer | MedSIR | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04680442 | Jul 2021 → Dec 2025 overdue | breast cancer, heart failure | Population Health Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04893109 | Jun 2021 → Nov 2026 expected | HER2 positive breast carcinoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT04589845 | Jan 2021 → Sep 2032 expected | cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04632992 | Jan 2021 → Dec 2023 | cancer of unknown primary site | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04351230 | Nov 2020 → Feb 2022 | HER2 positive breast carcinoma | Academic and Community Cancer Research United | Withdrawn | No outcome recorded |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | No outcome recorded |
| Phase 2 | NCT04341181 | Aug 2020 → Apr 2029 expected | cancer | Ulrik Lassen | Recruiting | No outcome recorded |
| Phase 2 | NCT04158947 | May 2020 → Dec 2023 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | xuexin he | Unknown | No outcome recorded |
| Phase 2 | NCT04266249 | Mar 2020 → Oct 2027 expected | invasive breast carcinoma | ECOG-ACRIN Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03820063 | Feb 2019 → Nov 2022 overdue | breast cancer | Dutch Breast Cancer Research Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03784599 | Dec 2018 → May 2021 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Terminated | No outcome recorded |
| Phase 2 | NCT03530696 | Dec 2018 → Dec 2022 | HER2 positive breast carcinoma, female breast carcinoma | University of Arizona | Completed | No outcome recorded |
| Phase 2 | NCT03587740 | Aug 2018 → Mar 2025 overdue | breast cancer | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03203616 | Feb → Aug 2018 | HER2 positive breast carcinoma | Jules Bordet Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT02314481 | May 2017 → Nov 2025 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02999672 | Dec 2016 → Apr 2018 | cholangiocarcinoma, malignant pancreatic neoplasm, urinary bladder cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02725541 | Mar 2016 → Apr 2019 | breast cancer | Jenny C. Chang, MD | Withdrawn | No outcome recorded |
| Phase 2 | NCT02675829 | Feb 2016 → Feb 2027 expected | lung cancer, urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04439110 | Aug 2015 → Mar 2019 overdue | plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03418558 | Jul 2015 → Jun 2019 | colorectal cancer | Fondazione del Piemonte per l'Oncologia | Unknown | No outcome recorded |
| Phase 2 | NCT02326974 | Jan 2015 → Jun 2018 overdue | HER2 positive breast carcinoma | Dana-Farber Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02289833 | Dec 2014 → Oct 2016 | non-small cell lung carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02073487 | Feb 2014 → Jan 2019 | breast cancer | The Methodist Hospital Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01975142 | Nov 2013 → Feb 2018 | Her2-receptor negative breast cancer | Institut Curie | Completed | No outcome recorded |
| Phase 2 | NCT01904903 | Oct 2013 → Jun 2019 | HER2 positive breast carcinoma | Medstar Health Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01702558 | Dec 2012 → May 2017 | breast cancer, gastric cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 2 | NCT01745965 | Nov 2012 → Feb 2015 | breast cancer | West German Study Group | Completed | No outcome recorded |
| Phase 2 | NCT03225937 | Aug 2012 → Dec 2018 | colorectal cancer | Fondazione del Piemonte per l'Oncologia | Unknown | No outcome recorded |
| Phase 2 | NCT01565200 | May 2012 → Jul 2017 | HER2 positive breast carcinoma | Jules Bordet Institute | Completed | No outcome recorded |
| Phase 2 | NCT01196052 | Oct 2010 → Jun 2013 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT01042379 | Mar 2010 → Dec 2030 expected | HER2 positive breast carcinoma, angiosarcoma, female breast carcinoma, hormone receptor-positive breast cancer +1 | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2 | NCT00943670 | Jul 2009 → Dec 2010 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00781612 | Oct 2008 → Sep 2029 expected | metastatic neoplasm | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00679341 | Sep 2008 → Nov 2010 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT00679211 | Aug 2008 → Sep 2009 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00509769 | Jul 2007 → Jan 2009 | breast cancer | Genentech, Inc. | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05288777 | Jul 2022 → Dec 2028 expected | breast cancer | University of Virginia | Recruiting | No outcome recorded |
| Phase 2/3 | NCT02568839 | Nov 2014 → Feb 2019 overdue | HER2 positive breast carcinoma | Thomas Hatschek | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT01641939 | Sep 2012 → Jun 2015 | gastric cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 313 trials | ||||||
| Phase 3 | NCT07673029 | Jan 2025 → Jan 2027 expected | HER2 positive breast carcinoma | GeneQuantum Healthcare (Suzhou) Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06316531 | May 2024 → May 2026 overdue | HER2 positive breast carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06265428 | Jan 2024 → Feb 2026 overdue | HER2 positive breast carcinoma | DualityBio Inc. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05429684 | Jan 2021 → Feb 2024 | HER2 positive breast carcinoma | First Affiliated Hospital Xi'an Jiaotong University | Unknown | No outcome recorded |
| Phase 3 | NCT03084939 | Apr 2017 → Nov 2018 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02131064 | Jun 2014 → Dec 2015 | breast neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02144012 | Jun 2014 → Jan 2016 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT01966471 | Jan 2014 → Nov 2019 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01772472 | Apr 2013 → Jul 2018 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01702571 | Nov 2012 → Jul 2020 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01419197 | Sep 2011 → Feb 2013 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT01120184 | Jul 2010 → Sep 2014 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00829166 | Feb 2009 → Jul 2012 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02658734 | Nov 2016 → Dec 2019 | HER2 positive breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05560308 | Sep 2022 → Aug 2024 | breast carcinoma by gene expression profile | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
| — | NCT06299852 | Jul 2022 → Sep 2025 | HER2 positive breast carcinoma | N.N. Petrov National Medical Research Center of Oncology | Unknown | No outcome recorded |
| — | NCT02226276 | Jan 2015 → Dec 2021 overdue | HER2 positive breast carcinoma, bone neoplasm, malignant soft tissue neoplasm, respiratory tract neoplasm | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT01120561 | May 2010 → ? | breast cancer | Genentech, Inc. | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 36 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04509596 Background | Sep 2020 → Jul 2022 | breast cancer | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04042051 Background | Nov 2019 → Nov 2020 | HER2 positive breast carcinoma | Cancer Trials Ireland | Terminated | No outcome recorded |
| Phase 1 | NCT03429101 Background | Jul 2018 → Apr 2019 | female breast carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | No outcome recorded |
| Phase 1/24 trials | ||||||
| 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 1/2 | NCT04298918 Background | Sep 2020 → Feb 2021 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1/2 | NCT05593094 Background | Sep 2020 → Aug 2027 expected | HER2 positive breast carcinoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03190967 Background | Apr 2018 → Jun 2021 | breast cancer, metastatic malignant neoplasm in the brain | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 212 trials | ||||||
| Phase 2 | NCT07421141 Background | Sep 2023 → Dec 2025 overdue | HER2 positive breast carcinoma | National Medical Research Radiological Centre of the Ministry of Health of Russia | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05323955 Background | Mar 2023 → Nov 2026 expected | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Carey Anders, M.D. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04301375 Background | Jun 2020 → Jul 2027 expected | breast cancer | David Garcia Cinca | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04398914 Background | May 2020 → Dec 2022 overdue | invasive breast carcinoma | Shanghai Jiao Tong University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04197687 Background | Feb 2020 → Jan 2025 | breast adenocarcinoma | Academic and Community Cancer Research United | Unknown | No outcome recorded |
| Phase 2 | NCT03894007 Background | May 2019 → Jun 2021 | HER2 positive breast carcinoma | Renske Altena | Terminated | No outcome recorded |
| Phase 2 | NCT02924883 Background | Sep 2016 → Dec 2017 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02448420 Comparator | Jul 2015 → Sep 2023 | breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 2 | NCT01597414 Comparator | Jun 2013 → Mar 2017 | breast cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT01853748 Comparator | May 2013 → Aug 2019 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01835236 Comparator | Mar 2013 → Jan 2018 | breast cancer | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01494662 Comparator | Feb 2012 → Feb 2023 | breast cancer | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04924699 Comparator | Jun 2021 → Sep 2023 | breast cancer | Shanghai Miracogen Inc. | Unknown | No outcome recorded |
| Phase 316 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 | NCT07008976 Comparator | Jul 2025 → Mar 2028 expected | breast cancer | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06830889 Comparator | Jun 2025 → Oct 2031 expected | HER2 positive breast carcinoma | Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06846437 Comparator | Feb 2025 → Oct 2026 expected | HER2 positive breast carcinoma | Shanghai JMT-Bio Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06313086 Comparator | Mar 2024 → Dec 2025 overdue | HER2 positive breast carcinoma | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06126640 Comparator | Nov 2023 → Apr 2030 expected | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06968585 Comparator | Jul 2023 → Nov 2026 expected | HER2 positive breast carcinoma | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05755048 Comparator | Mar 2023 → Jul 2025 | breast cancer | Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05415215 Background | Jul 2022 → Nov 2024 | female breast carcinoma, inflammatory breast carcinoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04740918 Background | Jun 2021 → Jun 2024 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 3 | NCT04873362 Background | May 2021 → Aug 2028 expected | breast cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04457596 Background | Mar 2021 → Jan 2028 expected | HER2 positive breast carcinoma, invasive breast carcinoma, synchronous bilateral breast carcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04622319 Comparator | Dec 2020 → Jul 2025 overdue | HER2 positive breast carcinoma, invasive breast carcinoma | Daiichi Sankyo | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03975647 Background | Oct 2019 → Jun 2023 overdue | HER2 positive breast carcinoma | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03726879 Background | Jan 2019 → Feb 2021 | breast cancer | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03529110 Comparator | Aug 2018 → May 2021 overdue | breast cancer | Daiichi Sankyo | Active not recruiting | No outcome recorded |
Press releases naming this drug 29 releases
| Date | Issuer | Release |
|---|---|---|
| 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 ↗ |
| 2025-09-29 | 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 ↗ |
| 2023-12-08 | Roche Global Development | Roche's Kadcyla is the first targeted therapy to show significant overall survival benefit in people with HER2-positive early-stage breast cancer with residual invasive disease after neoadjuvant treatment roche.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 ↗ |
| 2019-12-19 | Roche Global Development | European Commission approves Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment roche.com ↗ |
| 2019-11-15 | Roche Global Development | CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment roche.com ↗ |
| 2019-05-06 | Roche Global Development | FDA approves Roche's Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment roche.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 ↗ |
| 2019-02-05 | Roche Global Development | Roche submits supplemental biologics license application to US FDA for Kadcyla for adjuvant treatment of people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment roche.com ↗ |
| 2019-01-08 | AbbVie | ImmunoGen Announces Sale of Residual Kadcyla Royalties abbvie.com ↗ |
| 2018-12-05 | Roche Global Development | Roche's Kadcyla cut the risk of disease recurring by half compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment roche.com ↗ |
| 2018-10-15 | Roche Global Development | Roche's Kadcyla reduced the risk of disease recurring in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment roche.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 ↗ |
| 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 ↗ |
| 2016-09-28 | Daiichi Sankyo | Daiichi Sankyo to Present at ESMO 2016 Late-Breaking Clinical Data for Novel HER2-Targeting Antibody Drug Conjugate in T-DM1 Pre-Treated Breast Cancer daiichisankyo.com ↗ |
| 2013-11-20 | AbbVie | ImmunoGen, Inc. Announces Approval of Roche's Kadcyla® in the European Union abbvie.com ↗ |
| 2013-09-28 | AbbVie | ImmunoGen, Inc. Announces Results from Kadcyla® Phase III Trial, TH3RESA, Being Presented Today at the European Cancer Congress abbvie.com ↗ |
| 2013-09-20 | AbbVie | ImmunoGen, Inc. Announces Positive Regulatory Decisions for Roche's Kadcyla® in the European Union and Japan abbvie.com ↗ |
| 2013-02-22 | AbbVie | ImmunoGen, Inc. Announces FDA Approval of Kadcyla (Ado-Trastuzumab Emtansine; Also Known as T-DM1) abbvie.com ↗ |
| 2012-11-06 | AbbVie | ImmunoGen, Inc. Announces FDA Has Granted Priority Review Status to the Trastuzumab Emtansine (T-DM1) Marketing Application abbvie.com ↗ |
| 2012-10-01 | AbbVie | ImmunoGen, Inc. Announces Overall Survival Data Reported for Trastuzumab Emtansine (T-DM1) Phase III EMILIA Trial abbvie.com ↗ |
| 2012-08-27 | AbbVie | ImmunoGen, Inc. Announces Trastuzumab Emtansine (T-DM1) Significantly Improved Survival in the EMILIA Phase III Trial abbvie.com ↗ |
| 2012-06-03 | AbbVie | ImmunoGen, Inc. Announces Results from Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗ |
| 2012-06-03 | AbbVie | ImmunoGen, Inc. Announces Development of Trastuzumab Emtansine for Early Stage HER2-Positive Breast Cancer abbvie.com ↗ |
| 2012-03-30 | AbbVie | ImmunoGen, Inc. Announces Positive Results in Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗ |
| 2012-03-30 | AbbVie | ImmunoGen, Inc. Announces Conference Call at 8:00 am ET March 30, 2012 to Discuss Today's Favorable Announcements about Trastuzumab Emtansine (T-DM1) and about IMGN901 abbvie.com ↗ |
| 2011-09-24 | AbbVie | T-DM1 Significantly Improved Progression-Free Survival Compared to Standard of Care for Previously Untreated HER2-Positive Metastatic Breast Cancer abbvie.com ↗ |
| 2011-04-07 | AbbVie | T-DM1 Significantly Improved Progression-Free Survival in Randomized Phase II Trial abbvie.com ↗ |
| 2006-12-15 | AbbVie | ImmunoGen, Inc. Announces Presentation of First Clinical Data for Genentech's Trastuzumab-MCC-DM1 abbvie.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 145 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Trastuzumab Emtansine | “This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in...” NCT06265428 ↗96“A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With...” NCT06830889 ↗ “Patients with residual invasive disease in the resection specimen continued chemotherapy for a total of nine cycles, followed by 14 cycles of trastuzumab emtansine (3·6 kg/mg,...” PMID 41713473 ↗ Feb 2026 “Trastuzumab emtansine (T-DM1) is a standard treatment option in patients with previously treated human epidermal growth factor receptor 2 (HER2)-positive locally advanced or...” PMID 41260264 ↗ Nov 2025 “Patients with residual disease (ypT≥1b and/or ypN+ and/or RCB II-III) receive Trastuzumab emtansine (T-DM1) 3.6 mg/kg every 3 weeks for up to 14 cycles (combined with endocrine...” NCT07421141 ↗ “Molecular imaging as a tool to investigate heterogeneity of advanced HER2-positive breast cancer and to predict patient outcome under trastuzumab emtansine (T-DM1): the ZEPHIR trial.” PMID 26598545 ↗ Nov 2015 “single-agent trastuzumab emtansine (T-DM1) administered weekly and once every 3 weeks in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab.” PMID 22648179 ↗ May 2012 “trastuzumab emtansine given every 3 weeks at the standard dose (3.6 mg/kg) via intravenous infusion, until disease progression, intolerable toxicity or consent withdrawal.” NCT03203616 ↗ “Trastuzumab deruxtecan (T-DXd) demonstrated significantly improved efficacy over trastuzumab emtansine (T-DM1) in DESTINY-Breast03 (median follow-up, 28 months).” PMID 38825627 ↗ Jun 2024 “Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer” NCT07673029 ↗ “Treatment: Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks” NCT02562378 ↗ “The names of the study interventions involved in this study are: * Trastuzumab emtansine (also called T-DM1)” NCT02326974 ↗ “Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.” NCT02236000 ↗ “trastuzumab emtansine 3.6 mg/kg IV, repeated every 3 weeks, 6 courses” NCT02568839 ↗ “combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy” NCT02135159 ↗ “T-DM1 (Trastuzumab emtansine); Pertuzumab (Perjeta)” NCT01042379 ↗ “trastuzumab emtansine (T-DM1)” NCT06968585 ↗ “Trastuzumab emtansine (TDM-1)” NCT02448420 ↗ |
| Known as | ado-trastuzumab emtansine | “The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of tucatinib (ONT-380) combined...” NCT01983501 ↗12“Dual HER2 blockade with ado-trastuzumab emtansine (T-DM1) and lapatinib plus nab-paclitaxel has shown efficacy in patients with metastatic HER2-positive breast cancer.” PMID 31477168 ↗ Sep 2019 “T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.” NCT03429101 ↗ “-ado-trastuzumab emtansine (T-DM1)” NCT03587740 ↗ |
| Known as | Kadcyla | “Ado-trastuzumab emtansine (T-DM1 or Kadcyla) is an antibody drug conjugate used in second- and third- line treatment of metastatic human epidermal growth factor receptor 2...” NCT04296942 ↗6“Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla” NCT05755048 ↗ “Biological: Trastuzumab emtansine [Kadcyla]” NCT00943670 ↗ “Trastuzumab emtansine [Kadcyla] 3.0 mg/kg” NCT00875979 ↗ “Trastuzumab emtansine [Kadcyla]” NCT00679341 ↗ “Trastuzumab emtansine [Kadcyla]” NCT00679211 ↗ “Trastuzumab emtansine [Kadcyla]” NCT00509769 ↗ |
| Known as | Kadcyla, T-DM1 | “Kadcyla, T-DM1” NCT02289833 ↗1“KADCYLA=T-DM1” NCT01976169 ↗ |
| Known as | T-DM1 | “This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in...” NCT06265428 ↗58“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 ↗ “Patients with metastatic breast cancer considered HER2 negative are screened for HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is...” NCT01975142 ↗ “Patients with advanced colon rectal cancer (CRC) harboring an amplified HER2 that have been previously treated and progressed with an aNti-HER2 treatment, will be treated with...” NCT03418558 ↗ “The antibody-drug conjugate (ADCs) trastuzumab emtansine (T-DM1) is approved for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC)...” PMID 38751488 ↗ Jan 2023 “Trastuzumab emtansine (T-DM1) is a standard treatment option in patients with previously treated human epidermal growth factor receptor 2 (HER2)-positive locally advanced or...” PMID 41260264 ↗ Nov 2025 “A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease...” NCT06126640 ↗ “The phase III EMILIA and TH3RESA trials demonstrated clinical benefits of trastuzumab emtansine (T-DM1) therapy in patients with previously treated HER2-positive metastatic...” PMID 31146717 ↗ May 2019 “PREDIX HER2 is a randomized Phase II trial that compared neoadjuvant docetaxel, trastuzumab, and pertuzumab (THP) with trastuzumab emtansine (T-DM1) for HER2-positive breast cancer.” PMID 36449695 ↗ Feb 2023 “single-agent trastuzumab emtansine (T-DM1) administered weekly and once every 3 weeks in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab.” PMID 22648179 ↗ May 2012 “Trastuzumab emtansine (T-DM1), an antibody-drug conjugate of trastuzumab and the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor” PMID 30516102 ↗ Dec 2018 “This phase III trial compares the effect of usual treatment with trastuzumab emtansine (T-DM1) alone vs. T-DM1 in combination with tucatinib.” NCT04457596 ↗ “The aim of HERACLES-B trial is to assess the efficacy of the combination of pertuzumab and trastuzumab-emtansine (T-DM1) in this setting.” PMID 32988996 ↗ Sep 2020 “MRG002 versus Trastuzumab Emtansine (T-DM1) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer” NCT04924699 ↗ “Treatment: Trastuzumab emtansine (T-DM1) will be administered at a fixed dose of 3.6 mg/kg IV on Day 1 every 3 weeks” NCT02562378 ↗ “The names of the study interventions involved in this study are: * Trastuzumab emtansine (also called T-DM1)” NCT02326974 ↗ “Trastuzumab emtansine (T-DM1) will be administered as an intravenous (IV) infusion” NCT05081609 ↗ “trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus” NCT02131064 ↗ “replacing taxanes and trastuzumab with trastuzumab emtansine (T-DM1).” PMID 34890214 ↗ Dec 2021 “Active Comparator: Trastuzumab Emtansine (T-DM1) Trade name: Kadcyla” NCT05755048 ↗ “combined Trastuzumab Emtansine (T-DM1) and Whole-brain Radiotherapy” NCT02135159 ↗ “Ado trastuzumab emtansine (TDM1): 3.6mg/kg IV every three weeks.” NCT01904903 ↗ “trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab” PMID 26979312 ↗ Mar 2016 “if T-DM1: 3.6 mg/kg IV, every 3 weeks.” NCT01597414 ↗ “Trastuzumab emtansine (T-DM1)” NCT06846437 ↗ “Trastuzumab emtansine (T-DM1)” NCT01702558 ↗ “Trastuzumab Emtansine (T-DM1)” NCT06125834 ↗ “T-DM1” NCT01196052 ↗ |
| Known as | Trastuzumab emtansine (TDM-1) | “Trastuzumab emtansine (TDM-1)” NCT02448420 ↗ |
| Known as | Trastuzumab-MCC-DM1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01120561 ↗ |
| Action | Inhibit | “the cytotoxic agent emtansine (DM1), a maytansine derivative and microtubule inhibitor” PMID 30516102 ↗ Dec 2018 |
| Modality | Monoclonal antibody | “T-DM1 , which is a highly innovative but also expensive antiHER2 agent consisting in the coupling of the humanised monoclonal antibody trastuzumab with a cytotoxic agent...” NCT01565200 ↗ |
| Route | Intravenous | “trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion” NCT00509769 ↗ |
| Target | ERBB2 | “two human epidermal growth factor receptor 2 (HER2) -targeted agents, trastuzumab emtansine (T-DM1) and pertuzumab” PMID 24733796 ↗ Apr 2014 |