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
-

Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2011-09-01
Last Posted Date
2014-06-16
Lead Sponsor
Yale University
Registration Number
NCT01427244
Locations
🇺🇸

Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States

Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2011-07-26
Last Posted Date
2020-12-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
21
Registration Number
NCT01402401
Locations
🇺🇸

University of California at Los Angeles UCLA LeConte Location, Los Angeles, California, United States

🇺🇸

University of Texas/MD Anderson Cancer Center UT SC, Houston, Texas, United States

🇪🇸

Novartis Investigative Site, Barcelona, Cataluña, Spain

and more 1 locations

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-07-26
Last Posted Date
2018-06-15
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
127
Registration Number
NCT01401959
Locations
🇺🇸

The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

🇺🇸

Mercy Hospital, Portland, Maine, United States

🇺🇸

Texas Health Physician Group, Arlington, Texas, United States

and more 15 locations

Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

First Posted Date
2011-07-07
Last Posted Date
2015-08-28
Lead Sponsor
Vector Oncology
Target Recruit Count
12
Registration Number
NCT01388647
Locations
🇺🇸

Northwest Georgia Oncology Centers, Marietta, Georgia, United States

🇺🇸

Holy Cross Hospital, Fort Lauderdale, Florida, United States

🇺🇸

Northeast Georgia Cancer Care, Athens, Georgia, United States

and more 1 locations

An Open-label, Phase I/IIa, Dose Escalating Study of 2B3-101 in Patients With Solid Tumors and Brain Metastases or Recurrent Malignant Glioma.

First Posted Date
2011-07-01
Last Posted Date
2015-01-22
Lead Sponsor
BBB-Therapeutics B.V.
Target Recruit Count
84
Registration Number
NCT01386580
Locations
🇳🇱

Vrije Universiteit medisch centrum (Vumc), Amsterdam, Netherlands

🇺🇸

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

🇫🇷

Institut Curie, Paris, Paris Cedex 05, France

and more 7 locations

Intrathecal Trastuzumab Administration in Metastatic Breast Cancer Patients Developing Carcinomatous Meningitis

First Posted Date
2011-06-15
Last Posted Date
2019-07-10
Lead Sponsor
Institut Curie
Target Recruit Count
34
Registration Number
NCT01373710
Locations
🇫🇷

Institut du Cancer de Montpellier, Montpellier, France

🇫🇷

Institut Curie - Claudius Regaud Hospital, Paris, Ile De France, France

🇫🇷

Oscar Lambret Center, Lille, Nord, France

and more 7 locations

Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer

First Posted Date
2011-06-06
Last Posted Date
2023-05-17
Lead Sponsor
Yale University
Target Recruit Count
61
Registration Number
NCT01367002
Locations
🇺🇸

Jersey Shore University Medical Center, Neptune, New Jersey, United States

🇺🇸

The Ohio State University, Hilliard, Ohio, United States

🇺🇸

University of Arizona Cancer Center, Tucson, Arizona, United States

and more 17 locations

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

First Posted Date
2011-05-24
Last Posted Date
2024-06-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
4804
Registration Number
NCT01358877
Locations
🇺🇸

Texas Oncology - DFW, Dallas, Texas, United States

🇺🇸

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 552 locations

Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-04-22
Last Posted Date
2024-05-09
Lead Sponsor
Lucia Del Mastro,MD
Target Recruit Count
43
Registration Number
NCT01340430
Locations
🇮🇹

Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica, Torino, To, Italy

🇮🇹

Ospedale S. Maria della Misericordia - Oncologia Medica, Perugia, PG, Italy

🇮🇹

Istituto Nazionale per La Ricerca sul Cancro (IST), Genoa, Ge, Italy

and more 3 locations
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