Drugs / Trastuzumab emtansine
Trastuzumab emtansine
also known as
T-DM1 · ado-trastuzumab emtansine · Kadcyla · Kadcyla, T-DM1 · Trastuzumab emtansine (TDM-1) · Trastuzumab-MCC-DM1
Other / unclassified targets ERBB2
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 1 milestone | |||||
| Filed | US (FDA) | Kadcyla | female breast nipple and areola cancer | 2019-02-04 | “today announced completing the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for Kadcyla ® (ado-trastuzumab emtansine)” gene.com ↗ “today announced completing the submission of a supplemental Biologics License Application to the US Food and Drug Administration (FDA) for Kadcyla® (trastuzumab emtansine)” roche.com ↗ |
| Filed metastatic squamous cell carcinoma 2 milestones | |||||
| Filed | EU (EMA) | — | metastatic squamous cell carcinoma | 2012-10-01 | “Genentech and Roche have applied for marketing approval of trastuzumab emtansine in the US and Europe, respectively.” abbvie.com ↗ |
| Filed | US (FDA) | — | metastatic squamous cell carcinoma | 2012-08-27 | “Genentech and Roche have applied for marketing approval of trastuzumab emtansine in the US and Europe, respectively.” abbvie.com ↗ “Genentech has submitted a Biologics License Application (BLA) for trastuzumab emtansine to the US FDA” abbvie.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 99 · started per year
today
US approved 2013
EU approved 2013
1
1
3
6
4
1
7
4
13
8
5
6
5
1
6
9
5
5
3
4
2
20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| 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pancreatic ductal adenocarcinoma, pancreatic large cell neuroendocrine carcinoma +2 | OHSU Knight Cancer Institute | Withdrawn | No outcome recorded |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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 | Nancy Lin, 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 Stop: Enrollment |
| Phase 1/2 | NCT02658084 | Apr 2017 → Oct 2018 | breast cancer | University of Miami | Terminated | No outcome recorded Stop: Enrollment |
| 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 249 trials · 6 met primary · 2 missed | ||||||
| Phase 2 | NCT07825753 | Sep 2026 → Sep 2027 expected | breast cancer, pancreatic adenocarcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| 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 Stop: Enrollment |
| 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 Stop: Business |
| Phase 2 | NCT02675829 | Feb 2016 → Sep 2026 | lung cancer, urinary bladder cancer | Memorial Sloan Kettering Cancer Center | Completed | Met primary |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2027 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 2 | NCT01702558 | Dec 2012 → May 2017 | breast cancer, gastric cancer | Hoffmann-La Roche | Terminated | Missed primary |
| 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 | Missed primary |
| 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 | Met primary |
| 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 · 2 missed | ||||||
| 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 | Missed primary |
| Phase 2/3 | NCT01641939 | Sep 2012 → Jun 2015 | gastric cancer | Hoffmann-La Roche | Terminated | Missed primary |
| Phase 313 trials · 4 met primary · 3 missed | ||||||
| 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 | Met primary |
| 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 | Missed primary |
| Phase 3 | NCT02131064 | Jun 2014 → Dec 2015 | breast neoplasm | Hoffmann-La Roche | Completed | Missed primary |
| 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 | Missed primary |
| Phase 3 | NCT01772472 | Apr 2013 → Jul 2018 | breast cancer | Hoffmann-La Roche | Completed | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 |
| Comparator or background therapy35 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 Stop: Enrollment |
| Phase 1 | NCT03429101 Background | Jul 2018 → Apr 2019 | female breast carcinoma | Spectrum Pharmaceuticals, Inc | Terminated | 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 1/2 | NCT04298918 Background | Sep 2020 → Feb 2021 | breast cancer | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Business |
| 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 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 | 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 | Missed primary |
| 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 2/3 | NCT04924699 Comparator | Jun 2021 → Sep 2023 | breast cancer | Shanghai Miracogen Inc. | Unknown | No outcome recorded |
| 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 | Missed primary Stop: Enrollment |
| Phase 3 | NCT04873362 Background | May 2021 → Mar 2027 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 | Met primary |
| Phase 3 | NCT03975647 Background | Oct 2019 → Jun 2023 overdue | HER2 positive breast carcinoma | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT03726879 Background | Jan 2019 → Feb 2021 | breast cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT03529110 Comparator | Aug 2018 → May 2021 | breast cancer | Daiichi Sankyo | Completed | Met primary |
News releases announcing trial results or a regulatory action · 43
| Date | Issuer | Release |
|---|---|---|
| 2026-09-14 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Results from Phase III Study of Trastuzumab Botidotin versus T-DM1 in HER2-Positive Breast Cancer Published in JCO kelun-biotech.com ↗ |
| 2026-05-21 | Boehringer Ingelheim | Results Boehringer Ingelheim's oncology portfolio shows strong promise across multiple cancers at ASCO 2026 prnewswire.com ↗
Encouraging clinical activity was observed in heavily pretreated patients with HER2-positive mBC treated with HERNEXEOS in combination with trastuzumab emtansine (Cohort A) and trastuzumab deruxtecan (Cohort B). |
| 2025-10-19 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Results Kelun-Biotech Presents Positive Phase 3 Data for Trastuzumab Botidotin Compared to T-DM1 at 2025 ESMO kelun-biotech.com ↗
Median PFS was significantly longer in trastuzumab botidotin than in T-DM1 (11.1 months vs 4.4 months; HR: 0.39, 95% CI, 0.30-0.51, p<0.0001). |
| 2025-10-18 | AstraZeneca | Results 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 ↗
Results showed Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% compared with T-DM1 as a post-neoadjuvant treatment (based on an IDFS hazard ratio [HR] of 0.47, 95% confidence interval [CI] 0.34-0.66, p<0.0001). |
| 2025-09-29 | AstraZeneca | Results 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 ↗ |
| 2024-06-02 | AstraZeneca | Results 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 ↗
Results showed median OS was 52.6 months in the Enhertu arm compared to 42.7 months for T-DM1 (HR 0.73; 95% CI: 0.56-0.94). |
| 2023-12-11 | Chugai Pharmaceutical | Results Roche Announces Significant Overall Survival Benefit for Kadcyla in HER2-Positive Early-Stage Breast Cancer chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche issued a press release regarding Kadcyla to extend overall survival in the KATHERINE Phase 3 clinical trial for HER2-positive early breast cancer on December 8. |
| 2023-12-08 | Hoffmann-La Roche | Results 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 ↗
Kadcyla reduced the risk of disease recurrence or death from any cause by 46% compared to Herceptin (HR=0.54, 95% CI: (0.44, 0.66), p-value <0.0001), strengthening the results of the primary analysis of KATHERINE. |
| 2023-12-08 | Genentech, Inc. | Results Genentech’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 gene.com ↗
Long-term data also showed continued benefit in invasive disease-free survival for adjuvant Kadcyla compared to Herceptin in this study |
| 2022-12-07 | AstraZeneca | Results Enhertu achieved statistically significant overall survival, reducing the risk of death by 36% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer in DESTINY-Breast03 astrazeneca.com ↗
In the key secondary endpoint analysis of OS for DESTINY-Breast03, Enhertu demonstrated a 36% reduction in risk of death versus T-DM1 (based on a hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.47-0.87; p=0.0037). |
| 2022-12-07 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium pumabiotechnology.com ↗
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented updated findings from the Translational Breast Cancer Research Consortium (TBCRC) Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas. |
| 2021-12-09 | AstraZeneca | Results Enhertu additional analyses further reinforce ground-breaking efficacy in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
Additionally, in this subgroup, Enhertu improved PFS to a median of 15 months versus 3 months for T-DM1. |
| 2021-09-18 | AstraZeneca | Results Enhertu reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
At a prespecified interim analysis of DESTINY-Breast03, Enhertu demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] 0.28; 95% confidence interval [CI] 0.22-0.37; p=7.8x10 -22 ). |
| 2021-08-09 | AstraZeneca | Results Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer astrazeneca.com ↗
Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtansine (T-DM1). |
| 2020-08-21 | Chugai Pharmaceutical | Regulatory Chugai Obtains Approval for Additional Indication of Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗
Kadcyla obtained an additional indication of HER2-positive postoperative early breast cancer, in addition to the indication of HER2-positive inoperable or recurrent breast cancer. |
| 2019-12-19 | Hoffmann-La Roche | Regulatory 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 | Hoffmann-La Roche | Regulatory 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 ↗ |
| 2019-08-30 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication for Anti-HER2 Antibody Drug Conjugate Kadcyla for Adjuvant Therapy of HER2-Positive Early Breast Cancer chugai-pharm.co.jp ↗ |
| 2019-05-06 | Hoffmann-La Roche | Regulatory 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 ↗
The application was approved in just over 12 weeks under the US FDA's Real-Time Oncology Review pilot programme |
| 2019-05-03 | Genentech, Inc. | Regulatory FDA Approves Genentech's Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Invasive Disease After Neoadjuvant Treatment gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin® (trastuzumab)-based treatment. |
| 2019-02-05 | Hoffmann-La Roche | Regulatory 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 ↗
For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases. |
| 2019-02-04 | Genentech, Inc. | Regulatory Genentech Submits Supplemental Biologics License Application to FDA For Kadcyla for Adjuvant Treatment of People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment gene.com ↗
The FDA is reviewing the application under the Real-Time Oncology Review and Assessment Aid pilot programs, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. |
| 2018-12-05 | Hoffmann-La Roche | Results 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 ↗
At three years, 88.3% of people treated with Kadcyla in the adjuvant HER2-positive early breast cancer setting did not have their breast cancer return compared to 77.0% treated with Herceptin, an 11.3% improvement |
| 2018-12-05 | Genentech, Inc. | Results Genentech’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 gene.com ↗
At three years, 88.3 percent of people treated with Kadcyla did not have their breast cancer return compared to 77.0 percent treated with Herceptin, an 11.3 percent improvement |
| 2018-10-15 | Hoffmann-La Roche | Results 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 ↗
Kadcyla significantly improved invasive disease-free survival compared to Herceptin in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment |
| 2018-10-14 | Genentech, Inc. | Results Genentech’s Kadcyla Reduced the Risk of Disease Recurring in People With HER2-Positive Early Breast Cancer With Residual Disease After Neoadjuvant Treatment gene.com ↗
Phase III KATHERINE study shows Kadcyla® significantly improved invasive disease-free survival compared to Herceptin® in people with HER2-positive early breast cancer with residual disease after neoadjuvant treatment |
| 2018-06-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2018 ASCO Annual Meeting pumabiotechnology.com ↗ |
| 2018-03-09 | SPH-BIOCAD (HK) Limited | Regulatory 好事成双！上海医药两款重磅新药获批临床~ sphchina.com ↗
2017年6月30日，该药物临床试验申请获得国家药监局正式受理，并于近期收到药物临床试验批件。 |
| 2017-04-02 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Interim Results of Phase Ib/II FB-10 Trial of PB272 in Combination with Trastuzumab Emtansine (T-DM1) in HER2-Positive Metastatic Breast Cancer at the 2017 AACR Annual Meeting pumabiotechnology.com ↗
For the 16 patients who were evaluable for efficacy, the objective response (CR/PR) rate was 56%. |
| 2014-12-19 | AbbVie | Results ImmunoGen Reports Roche Has Provided an Update on the MARIANNE Trial abbvie.com ↗
Roche has reported the MARIANNE study showed the three regimens helped people live without their disease worsening (PFS) for a similar amount of time, meeting its non-inferiority endpoint as assessed by an Independent Review Committee. |
| 2013-11-20 | AbbVie | Regulatory ImmunoGen, Inc. Announces Approval of Roche's Kadcyla® in the European Union abbvie.com ↗ |
| 2013-09-28 | AbbVie | Results ImmunoGen, Inc. Announces Results from Kadcyla® Phase III Trial, TH3RESA, Being Presented Today at the European Cancer Congress abbvie.com ↗
Kadcyla was found to significantly extend duration of progression-free survival (PFS) compared to treatment with physician's choice (median 6.2 months vs. 3.3 months, respectively) and reduced the risk of disease progression or death by 47 percent (HR=0.528; p < 0.0001). |
| 2013-09-20 | AbbVie | Regulatory ImmunoGen, Inc. Announces Positive Regulatory Decisions for Roche's Kadcyla® in the European Union and Japan abbvie.com ↗
CHMP has issued a positive opinion for Kadcyla, with the European Commission decision expected by the end of 2013. |
| 2013-02-22 | AbbVie | Regulatory ImmunoGen, Inc. Announces FDA Approval of Kadcyla (Ado-Trastuzumab Emtansine; Also Known as T-DM1) abbvie.com ↗ |
| 2012-11-06 | AbbVie | Regulatory ImmunoGen, Inc. Announces FDA Has Granted Priority Review Status to the Trastuzumab Emtansine (T-DM1) Marketing Application abbvie.com ↗
today announced that Genentech , a member of the Roche Group, has disclosed that the U.S. Food and Drug Administration (FDA) has officially accepted the Biologics License Application (BLA) for trastuzumab emtansine and granted it Priority Review. |
| 2012-10-01 | AbbVie | Results ImmunoGen, Inc. Announces Overall Survival Data Reported for Trastuzumab Emtansine (T-DM1) Phase III EMILIA Trial abbvie.com ↗
Trastuzumab emtansine reduced risk of death by 32% compared to the standard-of-care treatment arm of the trial. |
| 2012-08-27 | AbbVie | Results ImmunoGen, Inc. Announces Trastuzumab Emtansine (T-DM1) Significantly Improved Survival in the EMILIA Phase III Trial abbvie.com ↗
today announced that Roche has reported that updated results from its EMILIA Phase III trial show that patients treated with trastuzumab emtansine had a significant improvement in OS compared to those randomized to standard-of-care therapy. |
| 2012-06-03 | AbbVie | Results ImmunoGen, Inc. Announces Results from Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗
Treatment with trastuzumab emtansine significantly improved progression-free survival (PFS) compared to treatment with lapatinib plus capecitabine, as assessed by an independent review committee. |
| 2012-03-30 | AbbVie | Results ImmunoGen, Inc. Announces Positive Results in Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗
Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). |
| 2011-09-24 | AbbVie | Results T-DM1 Significantly Improved Progression-Free Survival Compared to Standard of Care for Previously Untreated HER2-Positive Metastatic Breast Cancer abbvie.com ↗
Median PFS was significantly greater for patients receiving trastuzumab emtansine compared to those receiving Herceptin plus chemotherapy (median PFS of 14.2 months vs. 9.2 months, respectively; p = 0.035). |
| 2011-04-07 | AbbVie | Results T-DM1 Significantly Improved Progression-Free Survival in Randomized Phase II Trial abbvie.com ↗
This top-line information about T-DM1's performance in the first-line setting is very encouraging and adds to the favorable efficacy and safety data reported across a number of T-DM1 studies. |
| 2009-04-10 | AbbVie | Results ImmunoGen, Inc. Announces Presentations at the American Association for Cancer Research Annual Meeting abbvie.com ↗
Trastuzumab-DM1 antibody-drug conjugate is efficacious in lapatinib-resistant breast cancer cells |
| 2006-12-15 | AbbVie | Results ImmunoGen, Inc. Announces Presentation of First Clinical Data for Genentech's Trastuzumab-MCC-DM1 abbvie.com ↗
ImmunoGen, Inc. (Nasdaq: IMGN) announced the presentation today of the initial findings from a Phase I clinical study that evaluates Genentech's trastuzumab-MCC-DM1 for the treatment of HER2-positive metastatic breast cancer. |
All press releases naming this drug 53 releases
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 ↗97“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 ↗ |
| 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]” NCT00509769 ↗ “Trastuzumab emtansine [Kadcyla]” NCT00679341 ↗ “Trastuzumab emtansine [Kadcyla]” NCT00679211 ↗ |
| 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 ↗59“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 ↗ “Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate (ADC) consisting of the humanized anti-HER2 monoclonal antibody trastuzumab covalently linked to the cytotoxic...” NCT07825753 ↗ “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 |
| Known as | Trastuzumab emtansine (TDM-1) | “Trastuzumab emtansine (TDM-1)” NCT02448420 ↗1“Trastuzumab emtansine (T-DM1)” NCT04622319 ↗ |
| 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 |