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 59 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
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
CD274 positive Her2-receptor positive breast cancer predicted - sensitive Trastuzumab Phase III Actionable In a retrospective analysis of a Phase III trial (KATHERINE), CD274 (PD-L1) expression was associated with invasive disease-free survival (HR=0.66) in patients with Erbb2 (Her2)-positive breast cancer treated with adjuvant Herceptin (trastuzumab), who had residual invasive disease after neoadjuvant therapy (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 502-502; NCT01772472). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02774681 Phase II Trastuzumab Palbociclib Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis Terminated 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
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 | ITA | FRA | ESP | DEU 2
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 Active, not 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
NCT01750073 Phase II Doxorubicin Trastuzumab Cyclophosphamide + Paclitaxel Paclitaxel and Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Patients With Previously Untreated Stage I-III Breast Cancer Active, not recruiting 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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 7
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
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
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
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
NCT01367002 Phase II Trastuzumab Carboplatin + Paclitaxel Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer 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 | ITA | FRA | ESP 4
NCT03379428 Phase Ib/II Trastuzumab Ibrutinib + Trastuzumab Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer Active, not recruiting USA 0
NCT01570036 Phase II E75 Sargramostim Trastuzumab Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax 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 | ITA | FRA | ESP | DEU | CAN | BEL | AUT 10
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 | ITA | FRA | ESP | DEU | BEL | AUT 25
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
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 Recruiting 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
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
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 | ESP | DEU | CAN 4
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
NCT00912340 Phase II Everolimus Trastuzumab Randomized Phase II Trial of Trastuzumab or EVEROLIMUS in Hormone-refractory Metastatic Breast Cancer Completed USA 0
NCT01325207 Phase Ib/II Trastuzumab Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer 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) Recruiting ITA 0
NCT03521245 Phase I Trastuzumab Molecular Pathway Activation Markers Predicting Efficacy of Trastuzumab Therapy for HER2-positive Breast Cancer Active, not recruiting USA 1
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
NCT00796978 Phase II Trastuzumab Trastuzumab in Treating Older Women With Early-Stage Breast Cancer 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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 20
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
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 ITA | FRA | ESP | DEU | CAN 54
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 | AUT 8
NCT01928290 Phase II Trastuzumab Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal 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) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 34
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
NCT01480583 Phase II Trastuzumab GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases Completed 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
NCT00968968 Phase III Trastuzumab Lapatinib + Trastuzumab Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone Terminated USA | CAN 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 | ITA | FRA | ESP | DEU | CAN | BEL 31
NCT02260531 Phase II Cabozantinib Trastuzumab Cabozantinib + / - Trastuzumab In Breast Cancer Patients w/ Brain Metastases Completed USA 0
NCT02678182 Phase II Durvalumab Rucaparib Capecitabine Trastuzumab Capecitabine + Ramucirumab Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial (PLATFORM) Recruiting 1
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


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