MedPath

Trastuzumab

Generic Name
Trastuzumab
Brand Names
Herceptin, Herceptin Hylecta, Herzuma, Kanjinti, Ontruzant, Perjeta-Herceptin, Phesgo, Trazimera, Herwenda, Ogivri, Zercepac, Tuznue
Drug Type
Biotech
Chemical Formula
-
CAS Number
180288-69-1
Unique Ingredient Identifier
P188ANX8CK
Background

Produced in CHO cell cultures, trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein (HER2). It is used as a treatment of human epidermal growth factor receptor (HER)-2+ metastatic breast cancer, where there is a proven amplification of the HER-2 oncogene or over-expression of the HER-2 protein in tumours. It is suggested that the overexpression or gene amplification of HER2 has been found in about 20–30% of breast cancers and elevated activation of HER2 triggers multiple downstream pathways leading to abnormal proliferation of cancer cells . Trastuzumab binds to HER2 and suppresses cancer cell growth, proliferation, and survival directly and indirectly .

In December 2017, FDA approved OGIVRI (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data. While Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the U.S. for the treatment of cancer. Herzuma (trastuzumab-pkrb) is a biosimilar drug approved in December 2018 for the treatment of HER2-overexpressing breast cancer. KANJINTI (trastuzumab-anns) is another biosimilar approved by the FDA in June 2019. ONTRUZANT, another biosimilar of Herceptin, was approved by Health Canada in February 2022.

Indication

For the adjuvant treatment of HER2-overexpressing breast cancer, trastuzumab is indicated in several clinical settings: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as monotherapy following multi-modality anthracycline-based therapy.

Trastuzumab is indicated as a first-line treatment, in combination with paclitaxel, for metastatic HER2-overexpressing breast cancer, and as monotherapy in patients who have previously received one or more chemotherapy regimens in the metastatic setting.

Trastuzumab is also indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Trastuzumab is indicated for subcutaneous administration - in combination with either hyaluronidase or both hyaluronidase and pertuzumab - for the treatment of adults with HER2-positive breast cancers.

Associated Conditions
Breast Cancer, Inflammatory Breast Cancer (IBC), Locally Advanced Breast Cancer (LABC), Metastatic Adenocarcinoma of the Gastroesophageal Junction, Metastatic Adenocarcinoma of the Stomach, Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Stage I Breast Cancer
Associated Therapies
-

Randomized Neoadjuvant Study of Epirubicin and Docetaxel With/Without Capecitabine in Early Breast Cancer

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-04-03
Last Posted Date
2011-12-30
Lead Sponsor
Austrian Breast & Colorectal Cancer Study Group
Target Recruit Count
536
Registration Number
NCT00309556
Locations
🇦🇹

Hospital BHB St. Veit/Glan, Surgery, St. Veit a. d. Glan, Carinthia, Austria

🇦🇹

State Hospital Klagenfurt, Klagenfurt, Carinthia, Austria

🇦🇹

Hospital Guessing, Guessing, Burgenland, Austria

and more 23 locations

Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Phase 2
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2006-03-15
Last Posted Date
2016-11-03
Lead Sponsor
US Oncology Research
Target Recruit Count
136
Registration Number
NCT00303108
Locations
🇺🇸

Missouri Cancer Associates, Columbia, Missouri, United States

🇺🇸

Texas Cancer Center, Arlington, Texas, United States

🇺🇸

Hematology Oncology Associates of IL, Chicago, Illinois, United States

and more 50 locations

Trastuzumab and Oxaliplatin in Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2006-02-28
Last Posted Date
2021-10-28
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
25
Registration Number
NCT00297596
Locations
🇺🇸

Graves-Gilbert Clinic, Bowling Green, Kentucky, United States

🇺🇸

Oncology Hematology Care, Cincinnati, Ohio, United States

🇺🇸

Chattanooga Oncology and Hematology Associates, Chattanooga, Tennessee, United States

and more 4 locations

Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer

First Posted Date
2006-02-24
Last Posted Date
2025-01-10
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
121
Registration Number
NCT00295893
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Vinflunine Plus Trastuzumab in Human Epidermal Growth Factor Receptor 2 (HER2neu) Over-Expressing Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Neoplasms
Breast Cancer
Interventions
First Posted Date
2006-01-31
Last Posted Date
2013-08-09
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
32
Registration Number
NCT00284180
Locations
🇺🇸

Associates in Hematology Oncology, Chattanooga, Tennessee, United States

🇺🇸

Northeast Alabama Regional Medical Center, Anniston, Alabama, United States

🇺🇸

Tennessee Oncology, Nashville, Tennessee, United States

and more 7 locations

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Phase 3
Terminated
Conditions
Neoplasms, Breast
Interventions
First Posted Date
2006-01-09
Last Posted Date
2023-04-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
63
Registration Number
NCT00272987
Locations
🇧🇪

Novartis Investigative Site, Liege, Belgium

Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

Phase 2
Completed
Conditions
Breast Neoplasm
Interventions
First Posted Date
2005-12-29
Last Posted Date
2012-03-20
Lead Sponsor
Accelerated Community Oncology Research Network
Target Recruit Count
30
Registration Number
NCT00270894
Locations
🇺🇸

Arena Oncology Associates, Great Neck, New York, United States

🇺🇸

Advanced Medical Specialties, Miami, Florida, United States

🇺🇸

Northwest Georgia Oncology Centers, PC, Marietta, Georgia, United States

and more 4 locations

Caelyx, Cyclophosphamide and Herceptin in Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2005-11-28
Last Posted Date
2023-04-04
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
49
Registration Number
NCT00258960
Locations
🇪🇸

Hospital Puerta del Mar, Cadiz, Spain

🇪🇸

Hospital Clinic i Provincial, Barcelona, Spain

🇪🇸

Hospital Juan Canalejo, La Coruña, Spain

and more 9 locations

Vorinostat and Trastuzumab in Treating Patients With Metastatic or Locally Recurrent Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions
First Posted Date
2005-11-24
Last Posted Date
2014-06-02
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
16
Registration Number
NCT00258349
Locations
🇺🇸

Siouxland Hematology Oncology Associates, Sioux City, Iowa, United States

🇺🇸

Iowa Methodist Medical Center, Des Moines, Iowa, United States

🇺🇸

Woodwinds Health Campus, Woodbury, Minnesota, United States

and more 22 locations

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

First Posted Date
2005-11-21
Last Posted Date
2018-03-02
Lead Sponsor
Rita Sanghvi, Mehta
Target Recruit Count
48
Registration Number
NCT00256243
Locations
🇺🇸

Chao Family Comprehensive Cancer Center, Orange, California, United States

© Copyright 2025. All Rights Reserved by MedPath