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Therapy Name Ado-trastuzumab emtansine
Synonyms
Therapy Description

Kadcyla (ado-trastuzumab emtansine) is an antibody drug conjugate combined of the ERBB2 (HER2) monoclonal antibody, trastuzumab, and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Ado-trastuzumab emtansine Kadcyla T-DM1|trastuzumab emtansine HER2 (ERBB2) Antibody 53 Kadcyla (ado-trastuzumab emtansine) is an antibody drug conjugate combined of the ERBB2 (HER2) monoclonal antibody, trastuzumab, and an anti-tubulin agent, DM1, which results in tumor cell cytotoxicity (PMID: 24887180). Kadcyla (ado-trastuzumab emtansine) is FDA approved for metastatic ERBB2 (HER2)-positive (overexpression or gene amplification) breast cancer patients who have previously received trastuzumab and/or taxane, and for the adjuvant treatment of patients with ERBB2 (HER2)-positive early breast cancer who have residual invasive disease after taxane and trastuzumab-based treatment (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
PIK3CA mutant Her2-receptor positive breast cancer not predictive Ado-trastuzumab emtansine Phase III Actionable In a retrospective analysis of a Phase III trial (KATHERINE), adjuvant Kadcyla (ado-trastuzumab emtansine) treatment demonstrated similar invasive disease-free survival benefit over Herceptin (trastuzumab) in PIK3CA mutant (HR=0.54) and PIK3CA wild-type (HR=0.48) patients with Erbb2 (Her2)-positive breast cancer who had residual invasive disease after neoadjuvant therapy (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 502-502; NCT01772472). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02675829 Phase II Ado-trastuzumab emtansine Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers Recruiting USA 0
NCT04266249 Phase II Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Ado-trastuzumab emtansine Docetaxel + Pertuzumab + Trastuzumab Nab-paclitaxel + Pertuzumab + Trastuzumab CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy Recruiting USA 1
NCT01772472 Phase III Ado-trastuzumab emtansine Trastuzumab A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) Active, not recruiting USA | CAN 26
NCT03587740 Phase II Ado-trastuzumab emtansine ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer Active, not recruiting USA 0
NCT04457596 Phase III Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Tucatinib T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial Recruiting USA 0
NCT02289833 Phase II Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Completed USA 6
NCT01513083 Phase I Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine in Patients With HER2-Positive Metastatic Breast Cancer and Normal or Reduced Hepatic Function Completed USA | CAN 3
NCT01702571 Phase III Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment Completed CAN 42
NCT04591431 Phase II Everolimus Nivolumab Itacitinib Erlotinib Ponatinib Pemigatinib Ipatasertib Ipilimumab Cobimetinib Atezolizumab Palbociclib Entrectinib Vemurafenib Lapatinib Trastuzumab Brigatinib Alectinib Ado-trastuzumab emtansine Pertuzumab Vismodegib The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy (ROME) Recruiting 1
NCT01904903 Phase II Pertuzumab Ado-trastuzumab emtansine Trastuzumab Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) Completed USA 0
NCT01702558 Phase II Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Capecitabine A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer and Patients With HER2-Positive Locally Advanced / Metastatic Gastric Cancer Terminated CAN 11
NCT01641939 Phase III Docetaxel Paclitaxel Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer Terminated USA | CAN 26
NCT04351230 Phase II Abemaciclib + Ado-trastuzumab emtansine Ado-trastuzumab emtansine Abemaciclib With or Without T-DM1 for the Treatment of HER2-Positive Metastatic Breast Cancer Recruiting USA 0
NCT04733118 Phase II Ado-trastuzumab emtansine Pertuzumab + Trastuzumab Chemotherapy-Free pCR-Guided Strategy With Subcutaneous Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHERGAIN-2) Not yet recruiting 1
NCT04740918 Phase III Ado-trastuzumab emtansine + Atezolizumab Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC) (KATE3) Recruiting USA | CAN 22
NCT04197687 Phase II Ado-trastuzumab emtansine + Sargramostim + TPIV100 Ado-trastuzumab emtansine + Sargramostim Pertuzumab + Trastuzumab Ado-trastuzumab emtansine TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery Recruiting USA 0
NCT01816035 Phase I Ado-trastuzumab emtansine Ado-Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery Completed USA 0
NCT02657343 Phase Ib/II Ribociclib Trastuzumab Ado-trastuzumab emtansine An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer. Active, not recruiting USA 0
NCT04301375 Phase II Paclitaxel + Pertuzumab + Trastuzumab Ado-trastuzumab emtansine Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial) (ELPIS) Not yet recruiting 1
NCT03530696 Phase II Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) Recruiting USA 0
NCT03975647 Phase III Ado-trastuzumab emtansine + Tucatinib Ado-trastuzumab emtansine A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer Recruiting USA | CAN 16
NCT04298918 Phase Ib/II Ado-trastuzumab emtansine + Venetoclax Ado-trastuzumab emtansine A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer Terminated USA 4
NCT04873362 Phase III Ado-trastuzumab emtansine Trastuzumab Atezolizumab + Trastuzumab Ado-trastuzumab emtansine + Atezolizumab A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy (Astefania) Recruiting USA 31
NCT04931342 Phase II Cobimetinib Ado-trastuzumab emtansine Ipatasertib + Paclitaxel Atezolizumab + Bevacizumab A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors Recruiting USA | CAN 12
NCT01853748 Phase II Paclitaxel + Trastuzumab Ado-trastuzumab emtansine T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) Active, not recruiting USA 0
NCT00781612 Phase II Ado-trastuzumab emtansine + Trastuzumab Ado-trastuzumab emtansine + Paclitaxel Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Docetaxel Ado-trastuzumab emtansine + Capecitabine Ado-trastuzumab emtansine + Pertuzumab A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies Recruiting USA | CAN 37
NCT03529110 Phase III Trastuzumab deruxtecan Ado-trastuzumab emtansine DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Active, not recruiting USA | CAN 13
NCT04589845 Phase II Alectinib Ado-trastuzumab emtansine Ipatasertib GDC-0077 Entrectinib Atezolizumab Idasanutlin Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Recruiting USA | CAN 22
NCT03190967 Phase Ib/II Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Temozolomide T-DM1 Alone Versus T-DM1 and Metronomic Temozolomide in Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases Following Stereotactic Radiosurgery Recruiting USA 0
NCT04622319 Phase III Trastuzumab deruxtecan Ado-trastuzumab emtansine A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05) Recruiting USA | CAN 29
NCT02725541 Phase II Ado-trastuzumab emtansine Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer Withdrawn USA 0
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2


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