MedPath

Pertuzumab

Generic Name
Pertuzumab
Brand Names
Perjeta, Perjeta-Herceptin, Phesgo
Drug Type
Biotech
CAS Number
380610-27-5
Unique Ingredient Identifier
K16AIQ8CTM
Background

Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two lights chains that have 448 and 214 residues respectively. It was first approved by the FDA in 2012 for use with docetaxel and another HER2-targeted monoclonal antibody, trastuzumab, in the treatment of metastatic HER2-positive breast cancer. Its indicated conditions have since expanded to include use as both a neoadjuvant therapy and an adjuvant therapy in the treatment of HER2-positive breast cancers at high risk of recurrence.

Indication

Pertuzumab is indicated for intravenous administration in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. It is also indicated in combination with trastuzumab and other chemotherapies for the neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early-stage breast cancer as part of a complete treatment regimen and as adjuvant treatment in patients with HER2-positive early-stage breast cancer at high risk of recurrence.

Pertuzumab is also indicated for subcutaneous injection - in combination with trastuzumab and hyaluronidase - in the treatment of HER2-positive breast cancers in adults.

Associated Conditions
Inflammatory Breast Cancer (IBC), Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer, Stage I Breast Cancer

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2023-02-22
Last Posted Date
2023-02-22
Lead Sponsor
Biocad
Target Recruit Count
100
Registration Number
NCT05738993
Locations
🇷🇺

City Polyclinic №77, Saint Petersburg, Russian Federation

🇷🇺

X7 Clinical Research, Saint Petersburg, Russian Federation

Study to Evaluate the Efficacy and Safety of SYSA1901 vs. Perjeta® of HER2-Positive Breast Cancer

Phase 3
Recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2023-02-09
Last Posted Date
2023-02-09
Lead Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Target Recruit Count
560
Registration Number
NCT05720026
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

To Evaluate the Cardiac Safety of Pegylated Liposomal Doxorubicin Concurrently Plus Trastuzumab and Pertuzumab in the Adjuvant Setting for Early-stage HER-2-positive Breast Cancer: a Multicenter, Randomized Controlled Clinical Study

First Posted Date
2022-12-19
Last Posted Date
2022-12-19
Lead Sponsor
Shanghai Pudong Hospital
Target Recruit Count
204
Registration Number
NCT05656079
Locations
🇨🇳

Shanghai Pudong Hospital, Shanghai, China

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-12-06
Last Posted Date
2023-03-20
Lead Sponsor
Shengjing Hospital
Target Recruit Count
236
Registration Number
NCT05638594
Locations
🇨🇳

Shengjing Hospital of China Medical University, Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy

Phase 2
Recruiting
Conditions
Breast Neoplasm
HER2-positive Breast Cancer
HER2-negative Breast Cancer
Hormone Receptor Positive Tumor
Breast Cancer
Breast Tumors
Hormone Receptor Negative Tumor
Triple-Negative Breast Cancer (TNBC)
Locally Advanced Breast Cancer
Early-stage Breast Cancer
Interventions
First Posted Date
2022-10-17
Last Posted Date
2024-12-27
Lead Sponsor
Fudan University
Target Recruit Count
716
Registration Number
NCT05582499
Locations
🇨🇳

Fudan University Shanghai Cancer Center Shanghai, China, 200032, Shanghai, Shanghai, China

Dalpiciclib, Fulvestrant, Trastuzumab and Pertuzumab in HR Positive, HER2 Positive Metastatic Breast Cancer

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2022-10-12
Last Posted Date
2024-02-26
Lead Sponsor
Fudan University
Target Recruit Count
72
Registration Number
NCT05574881
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Pyrotinib Plus Trastuzumab Versus Pertuzumab Plus Trastuzumab

Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2022-10-10
Last Posted Date
2024-02-26
Lead Sponsor
Fudan University
Target Recruit Count
333
Registration Number
NCT05572645
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2022-07-25
Last Posted Date
2023-01-26
Lead Sponsor
EirGenix, Inc.
Target Recruit Count
135
Registration Number
NCT05471648
Locations
🇩🇪

CRS Clinical Research Services Berlin GmbH, Berlin, Germany

Precise Therapy for Refractory HER2 Positive Advanced Breast Cancer

Phase 3
Conditions
HER2+ Breast Cancer
Interventions
First Posted Date
2022-06-23
Last Posted Date
2022-06-23
Lead Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Target Recruit Count
120
Registration Number
NCT05429684
Locations
🇨🇳

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China

🇨🇳

Jin Yang, Xi'an, Shaanxi, China

A Study of ARX788 Combined With Pyrotinib Maleate Versus TCBHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Phase 2
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2022-06-22
Last Posted Date
2024-10-30
Lead Sponsor
Caigang Liu
Target Recruit Count
136
Registration Number
NCT05426486
Locations
🇨🇳

Shengjing Hospital affiliated to China Medical University, Shenyang, Liaoning, China

© Copyright 2025. All Rights Reserved by MedPath