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
-

MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies

First Posted Date
2010-11-07
Last Posted Date
2014-04-17
Lead Sponsor
University of California, San Francisco
Target Recruit Count
17
Registration Number
NCT01235897
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

First Posted Date
2010-09-20
Last Posted Date
2017-06-07
Lead Sponsor
GlaxoSmithKline
Registration Number
NCT01205217
Locations
🇪🇸

GSK Investigational Site, Castellón, Spain

CAPOX, Bevacizumab and Trastuzumab for Patients With HER2-Positive Metastatic Esophagogastric Cancer

First Posted Date
2010-08-31
Last Posted Date
2024-10-17
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
37
Registration Number
NCT01191697
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Terminated
Conditions
Interventions
First Posted Date
2010-08-24
Last Posted Date
2017-10-20
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
250
Registration Number
NCT01187381
Locations
🇷🇴

Cluj Clinical County Hospital; Oncology Dept, Cluj-Napoca, Romania

Trastuzumab and Vinorelbine in Advanced Breast Cancer

First Posted Date
2010-08-20
Last Posted Date
2019-01-23
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
31
Registration Number
NCT01185509
Locations
🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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

First Posted Date
2010-07-12
Last Posted Date
2022-06-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
369
Registration Number
NCT01160211
Locations
🇬🇧

Novartis Investigative Site, Sutton, United Kingdom

A Study of Bevacizumab Added to Trastuzumab Plus Docetaxel in the Neoadjuvant Setting in Participants With Early Stage HER2-Positive Breast Cancer

First Posted Date
2010-06-11
Last Posted Date
2018-03-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
152
Registration Number
NCT01142778
Locations
🇫🇷

Centre Leon Berard; Oncologie Genetique, Lyon, France

🇫🇷

Centre D'Oncologie de Gentilly; Oncology, Nancy, France

🇫🇷

Centre Radiotherapie Marie Curie, Arras, France

and more 25 locations

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

First Posted Date
2010-05-28
Last Posted Date
2016-08-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
72
Registration Number
NCT01132664
Locations
🇺🇸

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States

🇺🇸

Sarah Cannon Research Institute Sarah Cannon Cancer Center SC, Nashville, Tennessee, United States

🇬🇧

Novartis Investigative Site, Oxford, United Kingdom

and more 5 locations

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

First Posted Date
2010-05-18
Last Posted Date
2019-07-18
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
508
Registration Number
NCT01125566
Locations
🇦🇹

Ordensklinikum Linz GmbH - Barmherzige Schwestern, Linz, Austria

🇦🇷

Sanatorio Parque, Rosario, Argentina

🇺🇸

Ironwood Cancer and Research Centers, Chandler, Arizona, United States

and more 203 locations
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