Trastuzumab Overview

Introduction of Trastuzumab

Trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody (mAb) that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor (HER2) protein. It is produced in Chinese hamster ovary (CHO) cell culture. It is sold under the brand name Herceptin among others for the treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin. Trastuzumab was approved for medical use in the United States in 1998. It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.

Mechanism of Action of Trastuzumab

The HER (human epidermal growth factor receptor) protein, binds to human epidermal growth factor, and stimulates cell proliferation. In some cancers, notably certain types of breast cancer, HER2 is over-expressed and causes cancer cells to reproduce uncontrollably. HER2 extends across the cell membrane, and carries signals from outside the cell to the inside. Signaling compounds called mitogens (specifically EGF in this case) arrive at the cell membrane, and bind to the extracellular domain of the HER family of receptors. Those bound proteins then link (dimerize), activating the receptor. HER2 sends a signal from its intracellular domain, activating several different biochemical pathways. These include the PI3K/Akt pathway and the MAPK pathway. Signals on these pathways promote cell proliferation and the growth of blood vessels to nourish the tumor (angiogenesis). Because it was recognized that constitutive HER2 signaling can drive breast tumor development and progression, strategies were developed to therapeutically target HER2 activity. The first successful approach began with the development of a mouse mAb called 4D5, which targets an extracellular epitope of the HER2 protein. HER2-specific monoclonal antibody 4D5 blocked phosphorylation of HER2 and suppressed growth of HER2-positive breast cancer cell lines and xenografts. In order to translate 4D5 clinically, a derivative that includes the antigen binding loops of 4D5 and the human variable region and immunoglobulin G1 constant domains was constructed. The recombinant humanized anti-HER2 antibody that resulted from this effort is called trastuzumab. Trastuzumab achieved significant regression of human HER2-overexpressing tumor xenografts as monotherapy or in combination with cytotoxic chemotherapeutic agents. The mechanisms underlying the anticancer activity of trastuzumab are not completely known, but several have been proposed. Some studies have suggested that trastuzumab downregulates total levels of HER2 on the cell surface, which may ultimately reduce downstream PI3K and MAPK signaling. Trastuzumab has been shown to block cleavage of the extracellular domain of HER2, thus, preventing formation of the constitutively active membrane-bound 95-kiloDalton HER2 protein called p95 HER2. Trastuzumab may also selectively inhibit HER2-HER3 heterodimerization, reducing PI3K signaling. Induction of cell cycle arrest by trastuzumab is mediated by p27kip1 and inhibition of cdk2 activity. Furthermore, trastuzumab appears to reduce angiogenesis, which may result in increased permeability of blood vessels, potentially increasing delivery of drugs to the tumor. Finally, HER2-positive cells that become “coated” in trastuzumab will be recognized by specific immune cells, causing antibody-dependent cellular cytotoxicity (ADCC), or lysis of the antibody-bound cells.

Mechanism of action of TrastuzumabFig.1 Mechanism of action of Trastuzumab

Table 1. Clinical Projects of Trastuzumab*

NCT ID Status Conditions Lead Sponsor Update Time
NCT00003612 Active, not recruiting Breast Cancer Alliance for Clinical Trials in Oncology January 27, 2003
NCT00004067 Active, not recruiting Breast Cancer NSABP Foundation Inc January 27, 2003
NCT00005970 Active, not recruiting Breast Adenocarcinoma; HER2 Positive Breast Carcinoma; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7 National Cancer Institute (NCI) January 27, 2003
NCT00194714 Enrolling by invitation HER2/Neu Positive; HLA-A2 Positive Cells Present; Stage IV Breast Cancer; Stage IV Ovarian Cancer University of Washington September 19, 2005
NCT00238420 Active, not recruiting Bladder Urothelial Carcinoma; Stage I Bladder Cancer AJCC v6 and v7; Stage II Bladder Cancer AJCC v6 and v7; Stage III Bladder Cancer AJCC v6 and v7 National Cancer Institute (NCI) October 13, 2005
NCT00251433 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals November 10, 2005
NCT00254592 Active, not recruiting Breast Cancer University of California, Irvine November 16, 2005
NCT00272987 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals January 9, 2006
NCT00295893 Active, not recruiting Breast Cancer City of Hope Medical Center February 24, 2006
NCT00343109 Active, not recruiting HER2-positive Breast Cancer; Male Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer University of Washington June 22, 2006
NCT00367471 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals August 23, 2006
NCT00470704 Active, not recruiting Breast Cancer Nancy Lin, MD May 8, 2007
NCT00490139 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals June 22, 2007
NCT00513292 Active, not recruiting HER2/Neu Positive; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer National Cancer Institute (NCI) August 8, 2007
NCT00542451 Active, not recruiting Breast Cancer; Carcinoma of the Breast Eric Winer, MD October 11, 2007
NCT00543504 Active, not recruiting Advanced Cancer M.D. Anderson Cancer Center October 15, 2007
NCT00553358 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals November 5, 2007
NCT00567190 Active, not recruiting Metastatic Breast Cancer Genentech, Inc. December 4, 2007
NCT00618657 Active, not recruiting Breast Cancer; HER2-negative Breast Cancer; HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer University of California, Irvine February 20, 2008
NCT00667251 Active, not recruiting Breast Cancer Novartis Pharmaceuticals April 28, 2008
NCT00684983 Active, not recruiting HER2/Neu Positive; Recurrent Breast Carcinoma; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7 National Cancer Institute (NCI) May 28, 2008
NCT00769379 Active, not recruiting Ductal Breast Carcinoma In Situ; HER2/Neu Positive National Cancer Institute (NCI) October 9, 2008
NCT00770809 Active, not recruiting HER2/Neu Positive; Male Breast Carcinoma; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer National Cancer Institute (NCI) October 10, 2008
NCT00820872 Active, not recruiting Breast Cancer Alliance for Clinical Trials in Oncology January 12, 2009
NCT00878709 Active, not recruiting Breast Cancer Puma Biotechnology, Inc. April 9, 2009
NCT00999804 Active, not recruiting Breast Cancer Baylor Breast Care Center October 22, 2009
NCT01009918 Active, not recruiting Breast Cancer; Cardiac Toxicity University of South Florida November 9, 2009
NCT01022086 Recruiting Stage I-IV Breast Cancer (Neo-adjuvant, Adjuvant, Locally Advanced and Metastatic) St. Michael's Hospital, Toronto December 1, 2009
NCT01093612 Active, not recruiting Breast Cancer; Stage IV Breast Cancer City of Hope Medical Center March 26, 2010
NCT01104571 Active, not recruiting Breast Cancer Institute of Cancer Research, United Kingdom April 15, 2010
NCT01104935 Active, not recruiting Breast Cancer Comprehensive Support Project for Oncology Research April 16, 2010
NCT01160211 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals July 12, 2010
NCT01173341 Recruiting Breast Cancer Abramson Cancer Center of the University of Pennsylvania August 2, 2010
NCT01191697 Active, not recruiting Esophageal Cancer; Gastric Cancer Dana-Farber Cancer Institute August 31, 2010
NCT01196390 Active, not recruiting Esophageal Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Stage IB Esophageal Cancer AJCC v7; Stage IIA Esophageal Cancer AJCC v7; Stage IIB Esophageal Cancer AJCC v7; Stage IIIA Esophageal Cancer AJCC v7; Stage IIIB Esophageal Cancer AJCC v7 National Cancer Institute (NCI) September 8, 2010
NCT01273610 Active, not recruiting Breast Neoplasms; HER2/Neu Positive; Geriatric Health Services City of Hope Medical Center January 10, 2011
NCT01275677 Active, not recruiting Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7 National Cancer Institute (NCI) January 12, 2011
NCT01276041 Active, not recruiting Breast Cancer Memorial Sloan Kettering Cancer Center January 13, 2011
NCT01300962 Active, not recruiting Metastatic Breast Cancer UNC Lineberger Comprehensive Cancer Center February 23, 2011
NCT01304797 Active, not recruiting Breast Cancer Merrimack Pharmaceuticals February 25, 2011
NCT01306942 Active, not recruiting Metastatic Breast Cancer Spanish Breast Cancer Research Group March 2, 2011
NCT01325207 Active, not recruiting Breast Cancer Northwestern University March 29, 2011
NCT01340430 Active, not recruiting HER-2 Positive Breast Cancer Lucia Del Mastro,MD April 22, 2011
NCT01358877 Active, not recruiting Breast Cancer Hoffmann-La Roche May 24, 2011
NCT01367002 Active, not recruiting Endometrial Cancer Yale University June 6, 2011
NCT01373710 Active, not recruiting Metastatic Breast Cancer; Carcinomatous Meningitis Institut Curie June 15, 2011
NCT01376505 Recruiting Malignant Solid Tumour; Breast Cancer; Malignant Tumor of Colon; GIST; Ovarian Cancer Pravin Kaumaya June 20, 2011
NCT01396707 Active, not recruiting Metastatic or Recurrent Gastric Adenocarcinoma; Her-2 Positive Gastric Cancer Asan Medical Center July 19, 2011
NCT01434303 Active, not recruiting HER2/Neu Positive; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7 National Cancer Institute (NCI) September 14, 2011
NCT01491737 Active, not recruiting Breast Cancer Hoffmann-La Roche December 14, 2011
NCT01522768 Recruiting Esophageal Cancer; Gastric Cancer Memorial Sloan Kettering Cancer Center February 1, 2012
NCT01526369 Active, not recruiting Metastatic Breast Cancer Cancer Trials Ireland February 3, 2012
NCT01562288 Active, not recruiting Breast Cancer Alliance for Clinical Trials in Oncology March 23, 2012
NCT01566721 Active, not recruiting Breast Neoplasms Hoffmann-La Roche March 29, 2012
NCT01572038 Active, not recruiting Breast Neoplasms Hoffmann-La Roche April 5, 2012
NCT01722890 Recruiting HER2-positive Breast Cancer; TNM Stage II-IV Breast Cancer Cancer Trials Ireland November 7, 2012
NCT01730118 Recruiting Breast Neoplasms; Breast Cancer; Adenocarcinomas; Metastatic Solid Tumors Characterized by HER2/Neu Expression National Cancer Institute (NCI) November 21, 2012
NCT01730833 Recruiting HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Breast Adenocarcinoma; Inflammatory Breast Carcinoma City of Hope Medical Center November 21, 2012
NCT01750073 Recruiting Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; HER2/Neu Positive; Invasive Breast Carcinoma; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma University of Nebraska December 17, 2012
NCT01774786 Active, not recruiting Gastric Cancer Hoffmann-La Roche January 24, 2013
NCT01779050 Active, not recruiting Breast Neoplasms Washington University School of Medicine January 29, 2013
NCT01783756 Active, not recruiting Central Nervous System Metastases; HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer Jonsson Comprehensive Cancer Center February 5, 2013
NCT01785420 Recruiting Carcinoma Breast Stage I; HER2 Positive Breast Cancer Dr Rajendra A. Badwe February 7, 2013
NCT01796197 Active, not recruiting Breast Cancer Dana-Farber Cancer Institute February 21, 2013
NCT01810393 Active, not recruiting Breast Cancer Hoffmann-La Roche March 13, 2013
NCT01817452 Recruiting Breast Cancer West German Study Group March 25, 2013
NCT01827163 Active, not recruiting HER2-Positive Early Stage Breast Cancer Memorial Sloan Kettering Cancer Center April 9, 2013
NCT01850628 Recruiting Breast Cancer NSABP Foundation Inc May 9, 2013
NCT01855828 Active, not recruiting Her2-Positive Breast Cancer Yale University May 17, 2013
NCT01873833 Active, not recruiting HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer University of Southern California June 10, 2013
NCT01875367 Active, not recruiting Breast Cancer Spanish Breast Cancer Research Group June 11, 2013
NCT01875666 Active, not recruiting Breast Neoplasms UNC Lineberger Comprehensive Cancer Center June 12, 2013
NCT01912963 Active, not recruiting HER-2 Positive Breast Cancer Dana-Farber Cancer Institute July 31, 2013
NCT01921335 Active, not recruiting Brain Metastases From HER2 and Breast Cancer; Advanced HER2-positive Breast Cancer Dana-Farber Cancer Institute August 13, 2013
NCT01939275 Active, not recruiting Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IA Gastric Cancer; Stage IB Gastric Cancer; Stage IIA Gastric Cancer; Stage IIB Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer City of Hope Medical Center September 11, 2013
NCT01940497 Active, not recruiting Breast Cancer Hoffmann-La Roche September 12, 2013
NCT01950182 Recruiting Breast Cancer Sun Yat-sen University September 25, 2013
NCT01953926 Recruiting Malignant Solid Tumor; Fibrolamellar Carcinoma Puma Biotechnology, Inc. October 1, 2013
NCT01957332 Active, not recruiting Metastatic Breast Cancer University Medical Center Groningen October 8, 2013
NCT01959386 Active, not recruiting Breast Neoplasms Hoffmann-La Roche October 10, 2013
NCT01964391 Active, not recruiting Breast Cancer Hoffmann-La Roche October 17, 2013
NCT01969643 Recruiting Breast Cancer Seattle Genetics, Inc. October 25, 2013
NCT01989676 Active, not recruiting Metastatic Breast Cancer Pfizer November 21, 2013
NCT02003209 Active, not recruiting Estrogen Receptor Positive; HER2/Neu Positive; Progesterone Receptor Positive; Stage IB Breast Cancer AJCC v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7 National Cancer Institute (NCI) December 6, 2013
NCT02023996 Recruiting Esophagogastric Cancer Memorial Sloan Kettering Cancer Center December 30, 2013
NCT02025192 Active, not recruiting HER2 Positive Metastatic Breast Cancers Cascadian Therapeutics Inc. December 31, 2013
NCT02066532 Recruiting Metastatic Breast Cancer; Breast Carcinoma; HER-2 Positive Breast Cancer Kevin Kalinsky February 19, 2014
NCT02080390 Active, not recruiting Her 2 Positive Breast Cancer University of Florida March 6, 2014
NCT02091141 Recruiting Neoplasms Genentech, Inc. March 19, 2014
NCT02091960 Active, not recruiting HER2 Amplified; Advanced Breast Cancer; Human Epidermal Growth Factor Receptor 2 (HER2) Astellas Pharma Global Development, Inc. March 19, 2014
NCT02132949 Active, not recruiting Breast Cancer Hoffmann-La Roche May 7, 2014
NCT02139358 Active, not recruiting Breast Cancer H. Lee Moffitt Cancer Center and Research Institute May 15, 2014
NCT02152943 Recruiting Breast Cancer; Solid Tumors M.D. Anderson Cancer Center June 2, 2014
NCT02167854 Active, not recruiting Breast Cancer Memorial Sloan Kettering Cancer Center June 19, 2014
NCT02205047 Recruiting Malignant Neoplasm of Stomach; Malignant Neoplasm of Cardio-esophageal Junction of Stomach; Epidermal Growth Factor Receptor (EGFR) Protein Overexpression European Organisation for Research and Treatment of Cancer - EORTC July 31, 2014
NCT02213042 Active, not recruiting Neoplasms, Breast Novartis Pharmaceuticals August 11, 2014
NCT02214004 Recruiting Breast Cancer Gangnam Severance Hospital August 12, 2014
NCT02229149 Active, not recruiting Breast Neoplasms; Malignant Tumor of the Breast US Oncology Research August 29, 2014
NCT02236806 Recruiting Breast Cancer; Cardiotoxicity Azienda Ospedaliero-Universitaria Careggi September 11, 2014
NCT02252887 Active, not recruiting Metastatic HER2-Positive Breast Cancer Memorial Sloan Kettering Cancer Center September 30, 2014
NCT02260531 Active, not recruiting Breast Cancer; Brain Tumor - Metastatic Dana-Farber Cancer Institute October 9, 2014
NCT02277717 Active, not recruiting Solid Tumors Synthon Biopharmaceuticals BV October 29, 2014
NCT02286843 Recruiting Breast Cancer Metastases; HER2 Positive Breast Memorial Sloan Kettering Cancer Center November 10, 2014
NCT02297698 Recruiting Breast Cancer Cancer Insight, LLC November 21, 2014
NCT02336984 Active, not recruiting Breast Cancer H. Lee Moffitt Cancer Center and Research Institute January 13, 2015
NCT02339532 Recruiting Breast Cancer UNICANCER January 15, 2015
NCT02344472 Recruiting Metastatic Breast Cancer Prof. W. Janni January 26, 2015
NCT02362958 Recruiting HER2 Positive Breast Cancer Sun Yat-sen University February 13, 2015
NCT02419742 Recruiting Breast Cancer Hoffmann-La Roche April 17, 2015
NCT02422199 Active, not recruiting HER2 Positive Metastatic Breast Cancer Jiangsu HengRui Medicine Co., Ltd. April 21, 2015
NCT02436993 Recruiting Breast Carcinoma University of California, Irvine May 7, 2015
NCT02448420 Recruiting Metastatic Breast Cancer SOLTI Breast Cancer Research Group May 19, 2015
NCT02454777 Recruiting Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer University of Southern California May 27, 2015
NCT02488564 Recruiting HER-2 Positive Breast Cancer Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori July 2, 2015
NCT02492711 Recruiting HER-2 Positive Breast Cancer; Metastatic Neoplasm MacroGenics July 9, 2015
NCT02536339 Active, not recruiting Metastatic Breast Cancer Genentech, Inc. August 31, 2015
NCT02571530 Recruiting Neoplasm Metastasis Northwell Health October 8, 2015
NCT02586025 Active, not recruiting Breast Cancer Hoffmann-La Roche October 26, 2015
NCT02598310 Recruiting Breast Cancer; Estrogen Receptor Negative Neoplasm; HER-2 Positive Breast Cancer Osaka Medical College November 5, 2015
NCT02614794 Recruiting HER2 Positive Breast Cancer Cascadian Therapeutics Inc. November 25, 2015
NCT02615054 Active, not recruiting Trastuzumab Cardiotoxicity; HER2-Positive Breast Cancer Survivors Memorial Sloan Kettering Cancer Center November 25, 2015
NCT02625441 Recruiting Breast Cancer Helsinki University Central Hospital December 9, 2015
NCT02627274 Recruiting Solid Tumor; Breast Cancer; Cancer of Head and Neck Hoffmann-La Roche December 10, 2015
NCT02632435 Recruiting Breast Cancer; Cancer Ottawa Hospital Research Institute December 16, 2015
NCT02642458 Active, not recruiting Metastatic Breast Cancer University Hospital Tuebingen December 30, 2015
NCT02649686 Active, not recruiting Metastatic Breast Cancer Canadian Cancer Trials Group January 7, 2016
NCT02654119 Recruiting HER2 Positive Breast Carcinoma; Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7 University of Nebraska January 13, 2016
NCT02675231 Active, not recruiting Hormone Receptor Positive Tumor; HER-2 Positive Breast Cancer Eli Lilly and Company February 5, 2016
NCT02688998 Recruiting Breast Cancer; Cancer Ottawa Hospital Research Institute February 23, 2016
NCT02689284 Recruiting Gastric Cancer; Stomach Cancer; Esophageal Cancer MacroGenics February 23, 2016
NCT02689921 Active, not recruiting Breast Neoplasms Midwestern Regional Medical Center February 24, 2016
NCT02705859 Recruiting HER2 Positive Breast Cancer Cancer Trials Ireland March 11, 2016
NCT02726399 Active, not recruiting Gastric Cancer; Gastroesophageal Junction Cancer Memorial Sloan Kettering Cancer Center April 1, 2016
NCT02771795 Active, not recruiting Breast Neoplasms Samsung Bioepis Co., Ltd. May 13, 2016
NCT02772367 Recruiting Breast Cancer Memorial Sloan Kettering Cancer Center May 13, 2016
NCT02774421 Recruiting Posterior Fossa Ependymoma (PFEPN) University of Colorado, Denver May 17, 2016
NCT02789657 Recruiting Breast Cancer William Sikov June 3, 2016
NCT02805829 Not yet recruiting Gastric Cancer Xuzhou Medical University June 20, 2016
NCT02827877 Recruiting HER2 Positive Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer City of Hope Medical Center July 11, 2016
NCT02843126 Recruiting Recurrent Breast Cancer Fuda Cancer Hospital, Guangzhou July 25, 2016
NCT02852096 Recruiting Gastric Cancer; HER-2 Shanghai Zhongshan Hospital August 2, 2016
NCT02855775 Recruiting Breast Cancer Centre Hospitalier Universitaire de Besancon August 4, 2016
NCT02896855 Active, not recruiting Breast Cancer Hoffmann-La Roche September 12, 2016
NCT02901301 Recruiting Gastric Cancer Yonsei University September 15, 2016
NCT02907021 Recruiting Heart Failure; Breast Cancer Population Health Research Institute September 20, 2016
NCT02907918 Recruiting Breast Cancer; Cancer of Breast; Breast Carcinoma Washington University School of Medicine September 20, 2016
NCT02910219 Recruiting Breast Cancer Georgetown University September 21, 2016
NCT02954536 Recruiting Esophageal Cancer; Gastric Cancer Memorial Sloan Kettering Cancer Center November 3, 2016
NCT02993198 Recruiting HER2 Positive Breast Cancer; Cardiovascular Abnormalities Northwestern University December 15, 2016
NCT03013881 Active, not recruiting Breast Neoplasm United BioPharma January 9, 2017
NCT03043313 Recruiting Colorectal Adenocarcinoma; ERBB2 Gene Amplification; HER2/Neu Positive; KRAS wt Allele; NRAS wt Allele; Recurrent Colorectal Carcinoma; Stage III Colorectal Cancer AJCC v7; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IV Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7 Academic and Community Cancer Research United February 6, 2017
NCT03062007 Recruiting Metastatic Breast Cancer Biointegrator LLC February 23, 2017
NCT03084237 Recruiting Breast Cancer Shanghai Henlius Biotech March 20, 2017
NCT03094052 Recruiting HER2-positive Breast Cancer University of California, San Francisco March 29, 2017
NCT03101748 Recruiting Malignant Neoplasm of Breast M.D. Anderson Cancer Center April 5, 2017
NCT03112590 Recruiting Breast Cancer; Breast Cancer, Male; Breast Cancer Female; HER2-positive Breast Cancer H. Lee Moffitt Cancer Center and Research Institute April 13, 2017
NCT03125928 Recruiting HER2-positive Breast Cancer Fox Chase Cancer Center April 24, 2017
NCT03135171 Recruiting Breast Cancer University of Michigan Cancer Center May 1, 2017
NCT03140553 Recruiting HER2-Positive Breast Cancer Guangdong General Hospital May 4, 2017
NCT03144947 Recruiting Cancer, Breast Gruppo Oncologico Italiano di Ricerca Clinica May 9, 2017
NCT03161353 Recruiting Breast Cancer MedSIR May 19, 2017
NCT03179904 Recruiting HER2 Positive Breast Carcinoma; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer Mayo Clinic June 7, 2017
NCT03185988 Not yet recruiting Targeted Therapy; HER2; Biliary Tract Cancer; Esophageal Squamous Cell Carcinoma Shen Lin June 14, 2017
NCT03199300 Recruiting Toxicity Due to Chemotherapy; Cardiovascular Morbidity; Cancer, Treatment-Related University Medical Center Groningen June 26, 2017
NCT03199885 Not yet recruiting Breast Adenocarcinoma; HER2/Neu Positive; Recurrent Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7 National Cancer Institute (NCI) June 27, 2017
NCT03264547 Recruiting Breast Cancer Japan Breast Cancer Research Group August 29, 2017
NCT03272477 Recruiting Breast Neoplasms Palleos Healthcare GmbH September 5, 2017
NCT03273595 Recruiting Neoplasms, Breast Xijing Hospital September 6, 2017
NCT03281824 Enrolling by invitation HER2-positive Breast Cancer Alteogen, Inc. September 13, 2017
NCT03304080 Recruiting Breast Neoplasms; Breast Diseases Icahn School of Medicine at Mount Sinai October 6, 2017
NCT03321045 Recruiting Breast Cancer University of Alabama at Birmingham October 25, 2017
NCT03321981 Recruiting Breast Cancer Metastatic Merus N.V. October 26, 2017
NCT03329378 Not yet recruiting Locally Advanced Breast Cancer Icahn School of Medicine at Mount Sinai November 6, 2017
NCT03365882 Recruiting Colon Adenocarcinoma; ERBB2 Gene Amplification; Rectal Adenocarcinoma; Recurrent Colon Carcinoma; Recurrent Rectal Carcinoma; Stage III Colon Cancer AJCC v7; Stage III Rectal Cancer AJCC v7; Stage IIIA Colon Cancer AJCC v7; Stage IIIA Rectal Cancer AJCC v7; Stage IIIB Colon Cancer AJCC v7; Stage IIIB Rectal Cancer AJCC v7; Stage IIIC Colon Cancer AJCC v7; Stage IIIC Rectal Cancer AJCC v7; Stage IV Colon Cancer AJCC v7; Stage IV Rectal Cancer AJCC v7; Stage IVA Colon Cancer AJCC v7; Stage IVA Rectal Cancer AJCC v7; Stage IVB Colon Cancer AJCC v7; Stage IVB Rectal Cancer AJCC v7 Southwest Oncology Group December 7, 2017
NCT03367676 Not yet recruiting Breast Cancer Ruijin Hospital December 11, 2017
NCT03368131 Active, not recruiting Gastroesophageal Junction Adenocarcinoma Hebei Medical University December 11, 2017
NCT03368729 Not yet recruiting Metastatic Breast Cancer; HER2 Positive Breast Carcinoma University of Alabama at Birmingham December 11, 2017
NCT03379428 Recruiting Breast Neoplasms; Malignant Neoplasm of Breast US Oncology Research December 20, 2017
NCT03409848 Recruiting Gastric Cancer; Esophageal Cancer; Adenocarcinoma Gastric; HER2 Positive Gastric Cancer; Metastatic Gastric Cancer; GastroEsophageal Cancer AIO-Studien-gGmbH January 24, 2018
NCT03414658 Recruiting Breast Cancer Ian E. Krop, MD, PhD January 30, 2018
NCT03417544 Recruiting HER2-positive Metastatic Breast Cancer; Central Nervous System Metastases Nancy Lin, MD January 31, 2018
NCT03425656 Recruiting Malignant Neoplasm of Breast AryoGen Pharmed Co. February 7, 2018
NCT03457896 Recruiting Metastatic Colorectal Cancer NSABP Foundation Inc March 8, 2018
NCT03460067 Recruiting HER2-positive Breast Cancer Melissa Mitchell March 9, 2018
NCT03493854 Recruiting Early Breast Cancer Hoffmann-La Roche April 11, 2018
NCT03500380 Recruiting Breast Neoplasms; Breast Diseases; Capecitabine; HER2-positive Breast Cancer; HER2 Positive Breast Carcinoma RemeGen April 17, 2018
NCT03501979 Not yet recruiting Metastatic Breast Cancer; Leptomeningeal Disease University of Alabama at Birmingham April 18, 2018
NCT03505710 Recruiting Non-Small Cell Lung Cancer Daiichi Sankyo, Inc. April 23, 2018
NCT03507166 Recruiting Urothelial Carcinoma; Advanced Cancer RemeGen April 24, 2018
NCT03521245 Recruiting HER2-positive Breast Cancer OmicsWay Corp. May 10, 2018
NCT03523572 Recruiting Breast Cancer; Urothelial Carcinoma Daiichi Sankyo, Inc. May 14, 2018
NCT03556345 Recruiting Gastric Cancer; HER2 Overexpressing Gastric Carcinoma RemeGen June 14, 2018
NCT03556358 Recruiting Breast Cancer; Breast Neoplasms; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer Tanvex BioPharma USA, Inc. June 14, 2018
NCT03571633 Recruiting HER2-positive Breast Cancer; Operable Breast Cancer Centre Leon Berard June 27, 2018
NCT03588091 Recruiting HER2-positive Breast Cancer Jiangsu HengRui Medicine Co., Ltd. July 17, 2018
NCT03595592 Not yet recruiting Invasive Breast Cancer Fondazione Michelangelo July 23, 2018
NCT03613168 Not yet recruiting Cholangiocarcinoma; Biliary Tract Cancer; HER-2 Protein Overexpression; HER-2 Gene Amplification Changhoon Yoo August 2, 2018
NCT03615326 Recruiting Gastric Neoplasms; Gastroesophageal Junction Adenocarcinoma Merck Sharp & Dohme Corp. August 3, 2018
NCT03619044 Not yet recruiting HER2-positive Breast Cancer Institut Claudius Regaud August 7, 2018
NCT03674112 Not yet recruiting HER2-Positive Early Breast Cancer Hoffmann-La Roche September 17, 2018
NCT03680560 Not yet recruiting Solid Tumor; HER-2 Protein Overexpression Unum Therapeutics Inc. September 21, 2018
NCT03698383 Not yet recruiting HER2-positive Breast Cancer; Metastatic Breast Cancer Korean Cancer Study Group October 8, 2018

Table 2. Approved Drugs of Trastuzumab**

INN (trade name) Therapeutic area Dose Strength Route Company Marketing start Market
Herceptin HER2-Overexpressing Breast Cancer, HER2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Powder for solution 150 mg / 420 mg Intravenous infusion Genentech September 25, 1998 Trastuzumab Overview
Ontruzant Stomach Neoplasms, Breast Neoplasms Powder for solution 150 mg Intravenous infusion Samsung Bioepis UK Limited (SBUK) November 15, 2017 Trastuzumab Overview
Herzuma Stomach Neoplasms, Breast Neoplasms Powder for solution 150 mg Intravenous infusion Celltrion Healthcare Hungary Kft. February 9, 2018 Trastuzumab Overview
Kanjinti Stomach Neoplasms, Breast Neoplasms Powder for solution 150 mg Intravenous infusion Amgen Europe B.V., Breda May 16, 2018 Trastuzumab Overview
Herceptin Stomach Neoplasms, Breast Neoplasms Powder for solution 150 mg Intravenous infusion Roche Registration GmbH August 28, 2000 Trastuzumab Overview
Trazimera Stomach Neoplasms, Breast Neoplasms Powder for solution 150 mg Intravenous infusion Pfizer Europe MA EEIG July 26, 2018 Trastuzumab Overview
Herceptin HER2-Overexpressing Breast Cancer, HER2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Powder for solution 440 mg Subcutaneous Hoffmann-La Roche Limited August 23, 1999 Trastuzumab Overview
Herceptin SC HER2-Overexpressing Breast Cancer, HER2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Concentrate for solution 120 mg / mL Intravenous infusion Hoffmann-La Roche Limited September 11, 2018 Trastuzumab Overview
Herceptin HER2-Overexpressing Breast Cancer, HER2-Overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Powder for solution 60 mg
150 mg
Intravenous infusion Chugai Pharmaceutical Co., Ltd April 4, 2001 Trastuzumab Overview
Herceptin HER2-overexpressing Breast Cancer, HER2-overexpressing Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Powder for solution 150 mg Intravenous infusion Roche Products Pty Ltd September 14, 2000 Trastuzumab Overview
Herclon HER2-positive Early Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, Advanced Gastric Cancer Powder for solution 150 mg Intravenous infusion Roche Products Pty Ltd September 15, 2017 Trastuzumab Overview
Simabtra HER2-positive Early Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, Advanced Gastric Cancer Powder for solution 150 mg Intravenous infusion Celltrion Healthcare Australia Pty Ltd July 17, 2018 Trastuzumab Overview

What We Provide

Therapeutic Antibody

We provide high-quality for use in WB, FC, IP, ELISA, Neut, FuncS, IF and most other immunological methods. For lab research use only, not for diagnostic, therapeutic or any in vivo human use.

Reference
* The table was excerpted from the following website
https://clinicaltrials.gov/ct2/results?cond=&term=Trastuzumab

** Information presented in the table were collected from the following websites:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103792
https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=64277
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=73229
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=289147
http://search.tga.gov.au/s/search.html?collection=tga-artg&profile=record&meta_i=291750
https://www.ema.europa.eu/medicines/human/EPAR/kanjinti
https://www.ema.europa.eu/medicines/human/EPAR/herzuma
https://www.ema.europa.eu/medicines/human/EPAR/ontruzant
https://www.ema.europa.eu/medicines/human/EPAR/herceptin
https://www.ema.europa.eu/medicines/human/EPAR/trazimera
http://www.pmda.go.jp/PmdaSearch/iyakuDetail/GeneralList/4291406D3

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