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
-

Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer

First Posted Date
2018-12-06
Last Posted Date
2019-09-19
Lead Sponsor
Korean South West Oncology Group
Registration Number
NCT03766607
Locations
🇰🇷

Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of

GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-12-05
Last Posted Date
2024-11-05
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
47
Registration Number
NCT03765983
Locations
🇺🇸

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

Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer

First Posted Date
2018-11-28
Last Posted Date
2019-08-13
Lead Sponsor
Zhejiang Cancer Hospital
Target Recruit Count
100
Registration Number
NCT03756064
Locations
🇨🇳

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab

First Posted Date
2018-11-20
Last Posted Date
2024-08-28
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
138
Registration Number
NCT03747120
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

New Mexico Cancer Center, Albuquerque, New Mexico, United States

and more 2 locations

Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

Active, not recruiting
Conditions
First Posted Date
2018-11-13
Last Posted Date
2024-07-09
Lead Sponsor
University of Washington
Target Recruit Count
13
Registration Number
NCT03738553
Locations
🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, United States

A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

First Posted Date
2018-11-01
Last Posted Date
2024-11-05
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
454
Registration Number
NCT03726879
Locations
🇺🇸

Tennessee Oncology - Nashville, Nashville, Tennessee, United States

🇺🇸

HCA Midwest Division, Kansas City, Missouri, United States

🇺🇸

New York University Medical Center PRIME; NYU Langone Medical Center, New York, New York, United States

and more 73 locations

DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-10-23
Last Posted Date
2023-09-07
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
100
Registration Number
NCT03716180
Locations
🇺🇸

DF/BWCC in clinical affiliation with South Shore Hospital, South Weymouth, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

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

and more 2 locations

Study of ACTR T Cell Product in Combination With Trastuzumab in Subjects With HER2-Positive Advanced Solid Tumor Cancers

First Posted Date
2018-09-21
Last Posted Date
2020-03-31
Lead Sponsor
Cogent Biosciences, Inc.
Target Recruit Count
6
Registration Number
NCT03680560
Locations
🇺🇸

Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, Tennessee, United States

🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

🇺🇸

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

and more 3 locations

To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

First Posted Date
2018-08-23
Last Posted Date
2024-12-13
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
147
Registration Number
NCT03644186
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Berard, Lyon, France

🇮🇹

Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2, Aviano, Pordenone, Italy

and more 51 locations

Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (MK-3475-811/KEYNOTE-811)

First Posted Date
2018-08-03
Last Posted Date
2024-11-19
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
738
Registration Number
NCT03615326
Locations
🇪🇸

Hospital Universitario Central de Asturias ( Site 1402), Oviedo, Asturias, Spain

🇺🇸

Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0025), Philadelphia, Pennsylvania, United States

🇺🇸

University of Rochester ( Site 0041), Rochester, New York, United States

and more 189 locations
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