Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@genomenon.com
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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Ado-trastuzumab emtansine | Kadcyla | T-DM1|trastuzumab emtansine | HER2 (ERBB2) Antibody 78 HER2 (ERBB2) Antibody-Drug Conjugate 33 | 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). |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 | Active, not recruiting | USA | SVN | POL | NZL | NOR | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUS | 15 |
NCT01853748 | Phase II | Paclitaxel + Trastuzumab Ado-trastuzumab emtansine | T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) | Active, not recruiting | USA | 0 |
NCT02314481 | Phase II | Vemurafenib Atezolizumab + Carboplatin + Paclitaxel Atezolizumab + Carboplatin + Pemetrexed Disodium Atezolizumab + Cisplatin + Pemetrexed Disodium Atezolizumab Alectinib Ado-trastuzumab emtansine | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWINII) | Active, not recruiting | GBR | 0 |
NCT02465060 | Phase II | Erdafitinib Trametinib Crizotinib Sapanisertib Fexagratinib Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Active, not recruiting | USA | 2 |
NCT02675829 | Phase II | Ado-trastuzumab emtansine | Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers | Active, not recruiting | USA | 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 | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 5 |
NCT03587740 | Phase II | Ado-trastuzumab emtansine | ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer | Active, not 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 | Active, not recruiting | USA | SWE | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CHE | CAN | BEL | AUT | AUS | 5 |
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 | Active, not recruiting | USA | 1 |
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 |
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 | TUR | ROU | POL | NLD | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | ARG | 11 |
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 | HUN | ESP | DEU | BGR | 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) | Active, not recruiting | USA | TUR | ROU | POL | NZL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | BRA | BGR | BEL | AUT | AUS | 13 |
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 | TUR | ITA | GBR | FRA | ESP | DEU | CZE | CHE | CAN | AUS | 1 |
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 |
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 | TUR | SWE | SVN | SVK | POL | NOR | NLD | LUX | ITA | ISL | IRL | HUN | HRV | GRC | GBR | FRA | FIN | EST | ESP | DNK | DEU | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 15 |
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) | Completed | USA | TUR | SWE | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | ARG | 10 |
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 |
NCT01904903 | Phase II | Pertuzumab Ado-trastuzumab emtansine Trastuzumab | Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) | 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 | POL | ITA | ESP | DEU | CHE | 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 |
NCT03530696 | Phase II | Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib | T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) | 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 |
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 | 1 |
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 |
NCT04680442 | Phase II | Trastuzumab Ado-trastuzumab emtansine Pertuzumab | Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (SCHOLAR-2) | Recruiting | CAN | BRA | 1 |
NCT05288777 | Phase II | Capecitabine Ado-trastuzumab emtansine | Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer (Breast53) | Recruiting | USA | 0 |
NCT05408845 | Phase II | Docetaxel + Trastuzumab Ado-trastuzumab emtansine Trastuzumab deruxtecan | Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers | 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 | TUR | ROU | POL | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BRA | BEL | ARG | 12 |
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 | SVK | ITA | GRC | FRA | ESP | DEU | CAN | BRA | ARG | 3 |
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 |
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 |
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) | Terminated | ISR | FRA | CHE | BEL | AUS | 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) | Terminated | USA | TUR | POL | NOR | ITA | HRV | GBR | FRA | FIN | ESP | CAN | BRA | AUS | 6 |
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 | Unknown status | USA | 0 |
NCT04341181 | Phase II | Atezolizumab Niraparib Erlotinib Axitinib Cobimetinib + Vemurafenib Avelumab Pertuzumab + Trastuzumab Vismodegib Alectinib Ado-trastuzumab emtansine | ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling (ProTarget) | Unknown status | DNK | 0 |
NCT02725541 | Phase II | Ado-trastuzumab emtansine | Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer | Withdrawn | 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 |
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 |
CKB CORE allows for only a limited number of monthly page views for un-registered users. However, registration is free and allows for unlimited browsing of the CKB CORE content.
You have reached the monthly page view limit. For continued free access to CKB CORE, please register below: