Therapy Detail
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| Therapy Name | Ado-trastuzumab emtansine + Tucatinib |
| Synonyms | |
| Therapy Description | |
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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). |
| Tucatinib | Tukysa | ONT-380|ARRY-380|irbinitinib | HER2 Inhibitor 42 | Tukysa (tucatinib) selectivity inhibits ERBB2 (HER2), resulting in decreased proliferation and increased apoptosis in ERBB2 (HER2) expressing tumor cells (PMID: 28053022). Tukysa (tucatinib) in combination with Herceptin (trastuzumab) and Xeloda (capecitabine) is FDA approved for use in patients with advanced unresectable or metastatic ERBB2 (HER2)-positive breast cancer, including patients with brain metastasis, who have received prior anti-HER2 therapies, and in combination with Herceptin (trastuzumab) for patients with RAS wild-type ERBB2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| NCT05323955 | Phase II | Pertuzumab + Tucatinib Trastuzumab + Tucatinib Ado-trastuzumab emtansine + Tucatinib | Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib (BRIDGET) | Recruiting | USA | 0 |
| NCT06439693 | Phase II | Docetaxel + Pertuzumab + Trastuzumab Paclitaxel + Pertuzumab + Trastuzumab Trastuzumab deruxtecan Nab-paclitaxel + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab + Tucatinib Ado-trastuzumab emtansine + Tucatinib | The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer | Not yet recruiting | USA | 0 |
| NCT01983501 | Phase I | Ado-trastuzumab emtansine + Tucatinib | A Phase 1b Study of ONT-380 Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer | Completed | USA | CAN | 0 |
| NCT04632992 | Phase II | Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib Inavolisib Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) | Completed | USA | 0 |
| NCT05673928 | Phase II | Ado-trastuzumab emtansine + Tucatinib | A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) | Recruiting | USA | 0 |
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