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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 76 HER2 (ERBB2) Antibody-Drug Conjugate 31 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT01904903 | Phase II | Pertuzumab Ado-trastuzumab emtansine Trastuzumab | Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) | Completed | 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) | Recruiting | DNK | 0 |
| NCT05288777 | Phase II | Capecitabine Ado-trastuzumab emtansine | Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer (Breast53) | Recruiting | 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. | Completed | 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 | TUR | ROU | POL | NZL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | BRA | BGR | BEL | AUT | AUS | ARG | 16 |
| NCT02675829 | Phase II | Ado-trastuzumab emtansine | Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers | Recruiting | USA | 0 |
| 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 |
| 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 |
| 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 | SWE | SVN | POL | NZL | NOR | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUS | 15 |
| 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 |
| 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 |
| 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 |
| NCT01853748 | Phase II | Paclitaxel + Trastuzumab Ado-trastuzumab emtansine | T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial) | Active, not 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 |
| 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 | 2 |
| 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 |
| 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 |
| 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 |
| NCT03587740 | Phase II | Ado-trastuzumab emtansine | ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer | Active, not recruiting | 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 | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 5 |
| 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 |
| 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 |
| 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 | ISR | FRA | CHE | BEL | AUS | 1 |
| NCT03530696 | Phase II | Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib | T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) | 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 | SVK | ITA | GRC | FRA | ESP | DEU | CAN | BRA | ARG | 3 |
| NCT02725541 | Phase II | Ado-trastuzumab emtansine | Trial of Neoadjuvant Trastuzumab Emtansine in Patients With HER2-Equivocal Breast Cancer | Withdrawn | USA | 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 |
| 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 | |
| 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 |
| NCT02314481 | Phase II | Vemurafenib Atezolizumab Alectinib Ado-trastuzumab emtansine | Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity (DARWINII) | Active, not recruiting | GBR | 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) | Terminated | USA | TUR | SVN | POL | NOR | ITA | HRV | GRC | GBR | FRA | FIN | ESP | CAN | BRA | AUS | 6 |
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