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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 58 HER2 (ERBB2) Antibody-Drug Conjugate 19 Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate (ADC) comprised 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
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 ITA 0
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 Active, not recruiting USA 0
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 | ITA | FRA | ESP | DEU | BEL | AUT 24
NCT05288777 Phase II Capecitabine Ado-trastuzumab emtansine Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer (Breast53) Not yet 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) Recruiting ITA | ESP | DEU 2
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 31
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT03587740 Phase II Ado-trastuzumab emtansine ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer Active, not recruiting 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 ITA | FRA | ESP | DEU | CAN 7
NCT01853748 Phase II Paclitaxel + Trastuzumab Ado-trastuzumab emtansine T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) Active, not recruiting USA 0
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 Withdrawn 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
NCT02725541 Phase II Ado-trastuzumab emtansine Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer Withdrawn USA 0
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 | ITA | FRA | ESP | CAN 0
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 | ITA | FRA | ESP | DEU | CAN | BEL 8
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 2
NCT03530696 Phase II Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) Active, not recruiting USA 0
NCT02675829 Phase II Ado-trastuzumab emtansine Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers 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 | ITA | FRA | ESP | DEU | CAN | BEL 24
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 | ITA | ESP | DEU 3
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 | ITA | FRA | ESP | DEU | CAN | BEL 7
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 | ITA | FRA | ESP | DEU | CAN 17
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
NCT01641939 Phase III Docetaxel Paclitaxel Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer Terminated USA | ITA | FRA | ESP | DEU | CAN | BEL 21
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 ITA | FRA | ESP | DEU | CAN | BEL | AUT 36
NCT01904903 Phase II Pertuzumab Ado-trastuzumab emtansine Trastuzumab Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) Completed 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 ESP 0
NCT02314481 Phase II Vemurafenib Atezolizumab Alectinib Ado-trastuzumab emtansine Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWINII) Recruiting 1
NCT05238831 Phase II Vemurafenib Vinorelbine Palbociclib Irinotecan Alpelisib Capecitabine Atezolizumab Paclitaxel Entrectinib Cobimetinib Nab-paclitaxel Fulvestrant Carboplatin Olaparib Pertuzumab/trastuzumab/hyaluronidase-zzxf Niraparib Vismodegib Alectinib Letrozole Ado-trastuzumab emtansine Bevacizumab Eribulin Anastrozole SMMART Adaptive Clinical Treatment (ACT) Trial Not yet 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
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. Completed 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
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 | ITA | FRA | ESP | DEU | CAN | BEL 18
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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 20
NCT04675827 Phase II Ado-trastuzumab emtansine Pertuzumab/trastuzumab/hyaluronidase-zzxf De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade (Decrescendo) Recruiting FRA | BEL 1


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