Therapy Detail

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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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Trastuzumab Herceptin Anti HER2 HER2 (ERBB2) Antibody 76 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).

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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
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
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
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
NCT02260531 Phase II Cabozantinib Trastuzumab Cabozantinib + / - Trastuzumab In Breast Cancer Patients w/ Brain Metastases Completed 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
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
NCT00912340 Phase II Everolimus Trastuzumab Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast 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
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 | ROU | POL | NOR | LTU | ITA | ISR | IRL | HUN | HRV | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BGR | BEL | AUS | ARG 16
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
NCT01904903 Phase II Pertuzumab Ado-trastuzumab emtansine Trastuzumab Cardiac Safety Study in Patients With HER2+ Breast Cancer (SAFE-HEaRt) Completed USA 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
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
NCT01480583 Phase II Trastuzumab GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases 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) Active, not recruiting 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
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
NCT01928290 Phase II Trastuzumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer Completed USA 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
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
NCT05036005 FDA approved Pertuzumab + Trastuzumab Trastuzumab Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (NeoON) Recruiting DEU 0
NCT03521245 Phase I Trastuzumab Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer Unknown status USA 1
NCT03379428 Phase Ib/II Trastuzumab Ibrutinib + Trastuzumab Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer Active, not recruiting USA 0
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
NCT00971737 Phase II Trastuzumab Cyclophosphamide Cyclophosphamide and Vaccine Therapy With or Without Trastuzumab in Treating Patients With Metastatic Breast Cancer Completed USA 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
NCT00796978 Phase II Trastuzumab Trastuzumab in Treating Older Women With Early-Stage Breast Cancer Completed USA 0
NCT02774681 Phase II Trastuzumab Palbociclib Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis 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
NCT01367002 Phase II Trastuzumab Carboplatin + Paclitaxel Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer Completed 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
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
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
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
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
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
NCT01325207 Phase Ib/II Trastuzumab Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer Completed USA 0
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
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
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
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
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) Recruiting DNK 0
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
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
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
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
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
NCT01570036 Phase II E75 Sargramostim Trastuzumab Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax Completed 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 Suspended USA 0


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