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Therapy Name Ado-trastuzumab emtansine
Synonyms
Therapy Description

Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate (ADC) comprising 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 73 HER2 (ERBB2) Antibody-Drug Conjugate 27 Kadcyla (ado-trastuzumab emtansine) is an antibody-drug conjugate (ADC) comprising 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 (PMID: 36730339; NCT01772472). 36730339

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | GBR | FRA | ESP | DEU | CAN | BEL | AUS 6
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) Suspended FRA | BEL | AUS 3
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 | CAN 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 Withdrawn 0
NCT04733118 Phase II Ado-trastuzumab emtansine Pertuzumab + Trastuzumab Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer (PHERGAIN-2) Active, not recruiting ITA | ESP | DEU 2
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 NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 33
NCT01853748 Phase II Paclitaxel + Trastuzumab Ado-trastuzumab emtansine T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) Active, not recruiting USA 0
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 Active, not recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS 5
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
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
NCT03530696 Phase II Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) Completed 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 | ITA | ESP | DEU 3
NCT04680442 Phase II Trastuzumab Ado-trastuzumab emtansine Pertuzumab Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (SCHOLAR-2) Recruiting CAN 2
NCT02675829 Phase II Ado-trastuzumab emtansine Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers Recruiting USA 0
NCT02725541 Phase II Ado-trastuzumab emtansine Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer Withdrawn USA 0
NCT03587740 Phase II Ado-trastuzumab emtansine ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer Active, not recruiting USA 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 Terminated USA 0
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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT 19
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
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 AUS 1
NCT01904903 Phase II Pertuzumab Ado-trastuzumab emtansine Trastuzumab Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) 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
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) Active, not recruiting ITA 0
NCT05408845 Phase II Docetaxel + Trastuzumab Ado-trastuzumab emtansine Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) for Recurrent, Metastatic, or Unresectable HER2-Positive Salivary Gland Cancer Recruiting USA 0
NCT04589845 Phase II Alectinib Ado-trastuzumab emtansine Ipatasertib Inavolisib Entrectinib Atezolizumab Idasanutlin Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study Recruiting USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 14
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
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 | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 23
NCT05288777 Phase II Capecitabine Ado-trastuzumab emtansine Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer (Breast53) 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
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
NCT02314481 Phase II Vemurafenib Atezolizumab Alectinib Ado-trastuzumab emtansine Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWINII) Active, not recruiting GBR 0
NCT06348134 Phase II Tamoxifen Ado-trastuzumab emtansine + Docetaxel + Pertuzumab Letrozole Ado-trastuzumab emtansine Goserelin Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery Not yet recruiting USA 0
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) Active, not recruiting USA | ITA | GBR | FRA | ESP | CAN | AUS 14
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
NCT01641939 Phase III Docetaxel Paclitaxel Ado-trastuzumab emtansine A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer Terminated USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 20
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 28
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) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 21
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 9


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