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Therapy Name | Trastuzumab |
Synonyms | |
Therapy Description |
Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Trastuzumab | Herceptin | Anti HER2 | HER2 (ERBB2) Antibody 78 | Herceptin (trastuzumab) is a monoclonal antibody, which binds ERBB2 (HER2) to induce tumor cellular cytotoxicity (PMID: 17611206). Herceptin (trastuzumab) is FDA approved for HER2-overexpressing (or amplification) breast cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
ARID1A loss | Her2-receptor positive breast cancer | resistant | Trastuzumab | Preclinical - Cell culture | Actionable | In a preclinical study, ERBB2 (HER2) positive breast cancer cells with ARID1A loss demonstrated resistance to Herceptin (trastuzumab) in culture (PMID: 27172896). | 27172896 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01750073 | Phase II | Doxorubicin Trastuzumab Cyclophosphamide + Paclitaxel | Paclitaxel and Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Patients With Previously Untreated Breast Cancer | Active, not recruiting | USA | 0 |
NCT02678182 | Phase II | Durvalumab Rucaparib Capecitabine Trastuzumab Capecitabine + Ramucirumab | Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM) | Active, not recruiting | GBR | 0 |
NCT02947685 | Phase III | Fulvestrant Pertuzumab Letrozole Anastrozole Exemestane Palbociclib Trastuzumab | Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA) | Active, not recruiting | USA | NZL | ITA | FRA | ESP | DEU | AUS | 1 |
NCT03379428 | Phase Ib/II | Trastuzumab Ibrutinib + Trastuzumab | Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer | Active, not recruiting | 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 |
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 |
NCT00574587 | Phase Ib/II | Paclitaxel + Vorinostat Trastuzumab Cyclophosphamide + Doxorubicin | Trial for Locally Advanced Her2 Positive Breast Cancer Using Paclitaxel, Trastuzumab, Doxorubicin and Cyclophasmide on a Weekly Basis | Completed | USA | 0 |
NCT00796978 | Phase II | Trastuzumab | Trastuzumab in Treating Older Women With Early-Stage Breast Cancer | Completed | USA | 0 |
NCT00912340 | Phase II | Everolimus Trastuzumab | Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer | Completed | USA | 0 |
NCT00971737 | Phase II | Trastuzumab Cyclophosphamide | Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer | Completed | USA | 0 |
NCT01106898 | Phase II | Cyclophosphamide + Paclitaxel Trastuzumab | Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery | Completed | USA | 0 |
NCT01160211 | Phase III | Lapatinib + Trastuzumab Letrozole Anastrozole Lapatinib Trastuzumab Exemestane | A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer | Completed | USA | TUR | POL | ITA | ISR | HUN | HRV | GRC | GBR | FRA | ESP | DEU | BRA | BGR | BEL | AUS | ARG | 12 |
NCT01325207 | Phase Ib/II | Trastuzumab | Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer | Completed | USA | 0 |
NCT01358877 | Phase III | Pertuzumab Epirubicin Cyclophosphamide Paclitaxel Docetaxel Trastuzumab Fluorouracil Carboplatin Doxorubicin | A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer (APHINITY) | Completed | USA | SWE | SVN | ROU | POL | NZL | NLD | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BGR | BEL | AUT | AUS | ARG | 17 |
NCT01367002 | Phase II | Trastuzumab Carboplatin + Paclitaxel | Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer | Completed | USA | 0 |
NCT01480583 | Phase II | Trastuzumab | GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases | Completed | USA | 0 |
NCT01491737 | Phase II | Anastrozole Letrozole Trastuzumab Pertuzumab + Trastuzumab | A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN) | Completed | USA | TUR | ITA | GBR | FRA | ESP | BRA | 1 |
NCT01566721 | Phase III | Trastuzumab | A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer) | Completed | TUR | SWE | SVN | SVK | ROU | POL | NZL | NOR | NLD | LTU | ITA | IRL | HUN | HRV | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BGR | AUS | ARG | 33 |
NCT01570036 | Phase II | E75 Sargramostim Trastuzumab | Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax | Completed | 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) | Completed | USA | TUR | SWE | ITA | ISR | IRL | GRC | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BRA | BEL | AUT | ARG | 10 |
NCT01875666 | Phase I | Lapatinib + Trastuzumab Trastuzumab Pertuzumab Pertuzumab + Trastuzumab | Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib | 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 |
NCT01928290 | Phase II | Trastuzumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin | Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer | Completed | USA | 0 |
NCT02213289 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Docetaxel + Fluorouracil Trastuzumab Fluorouracil + Irinotecan + Leucovorin Rilotumumab | PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression | Completed | USA | 0 |
NCT02260531 | Phase II | Cabozantinib Trastuzumab | Cabozantinib + / - Trastuzumab In Breast Cancer Patients w/ Brain Metastases | Completed | USA | 0 |
NCT02286843 | Phase I | Trastuzumab | Can HER2 Targeted 89Zr-trastuzumab PET/CT Identify Unsuspected HER2 Positive Breast Cancer Metastases, Which Are Amenable to HER2 Targeted Therapy? | Completed | USA | 0 |
NCT02297698 | Phase II | Sargramostim Trastuzumab E75 | Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-risk HER2+ Breast Cancer Patients | Completed | USA | 0 |
NCT02390427 | Phase I | Trastuzumab Paclitaxel Pertuzumab Taselisib | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer | Completed | USA | 0 |
NCT02492711 | Phase III | Vinorelbine Capecitabine Gemcitabine Trastuzumab Eribulin Margetuximab-cmkb | Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer | Completed | USA | POL | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUT | 3 |
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 |
NCT02675231 | Phase II | Trastuzumab Abemaciclib + Trastuzumab Abemaciclib + Fulvestrant + Trastuzumab | A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER) | Completed | USA | ITA | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 2 |
NCT02924883 | Phase II | Trastuzumab Atezolizumab + Trastuzumab | A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy (KATE2) | Completed | USA | ITA | GBR | ESP | DEU | CAN | AUS | 2 |
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 |
NCT04928261 | FDA approved | Trastuzumab | Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy | Recruiting | CAN | 0 |
NCT04993014 | Phase II | Trastuzumab Pertuzumab + Trastuzumab | Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer (HER2Cell) | Recruiting | BRA | 0 |
NCT05376878 | FDA approved | Trastuzumab Trastuzumab deruxtecan | An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis | Recruiting | USA | 0 |
NCT05725200 | Phase II | Dasatinib Palbociclib Gemcitabine Trastuzumab Cetuximab Pertuzumab Panobinostat Alectinib Venetoclax Larotrectinib Encorafenib Everolimus Idelalisib Crizotinib Pembrolizumab Methotrexate Talazoparib | Study to Investigate Outcome of Individualized Treatment in Patients With Metastatic Colorectal Cancer (EVIDENT) | Recruiting | NOR | 0 |
NCT06441890 | Phase II | Trastuzumab Docetaxel Paclitaxel Nab-paclitaxel Pertuzumab | BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer (BRE-10) | Recruiting | USA | 0 |
NCT00968968 | Phase III | Trastuzumab Lapatinib + Trastuzumab | Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone | Terminated | USA | CAN | 0 |
NCT01779050 | Phase II | Trastuzumab Docetaxel Cyclophosphamide + Epirubicin Paclitaxel Cyclophosphamide + Epirubicin + Fluorouracil Carboplatin + Docetaxel Cyclophosphamide + Docetaxel | Effect of Trastuzumab on Disease Free Survival in Early Stage HER2-Negative Breast Cancer Patients With ERBB2 Expressing Disseminated Tumor Cells | Terminated | USA | 0 |
NCT01912963 | Phase II | Eribulin Pertuzumab Trastuzumab | Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer | Terminated | USA | 0 |
NCT02213042 | Phase II | Lapatinib + Trastuzumab Trastuzumab | Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer | Terminated | USA | ITA | ESP | BRA | AUT | ARG | 6 |
NCT02229149 | Phase II | Paclitaxel Docetaxel Pertuzumab + Trastuzumab Nab-paclitaxel Vinorelbine Trastuzumab Capecitabine | Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer | Terminated | USA | 0 |
NCT02571530 | Phase I | Trastuzumab | Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer | Terminated | USA | 0 |
NCT02774681 | Phase II | Trastuzumab Palbociclib | Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis | Terminated | USA | 0 |
NCT03432741 | Phase I | Carfilzomib Daratumumab Obinutuzumab Gemcitabine Trastuzumab Romidepsin Nivolumab Rituximab Belinostat Pembrolizumab | Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer | Terminated | USA | 0 |
NCT03521245 | Phase I | Trastuzumab | Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer | Unknown status | USA | 1 |
NCT05036005 | FDA approved | Pertuzumab + Trastuzumab Trastuzumab | Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (NeoON) | Unknown status | DEU | 0 |
NCT05170256 | Phase II | Trastuzumab | Trastuzumab and Standard Treatment With Chemo- and Immunotherapy as First Line Treatment for HER2 Positive Esophageal Squamous Cell Carcinoma Patients (HERES) | Unknown status | DNK | 0 |
NCT02336984 | Phase Ib/II | Trastuzumab HER2-pulsed DC1 vaccine | A Phase I/II Trial of HER-2/Neu Pulsed DC1 Vaccine Combined With Trastuzumab for Patients With DCIS | Withdrawn | USA | 0 |
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