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

Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)
First Posted Date
2021-03-29
Last Posted Date
2021-03-29
Lead Sponsor
The Affiliated Hospital of Qingdao University
Target Recruit Count
88
Registration Number
NCT04820439
Locations
🇨🇳

Phase I Clinical Research Center, Qingdao, Shandong, China

Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09)

Phase 3
Active, not recruiting
Conditions
Breast Cancer; HER2-positive; Metastatic
Interventions
First Posted Date
2021-03-05
Last Posted Date
2025-05-06
Lead Sponsor
AstraZeneca
Target Recruit Count
1157
Registration Number
NCT04784715
Locations
🇬🇧

Research Site, Taunton, United Kingdom

TKIs vs. Pertuzumab in HER2+ Breast Cancer Patients With Active Brain Metastases (HER2BRAIN)

Phase 2
Not yet recruiting
Conditions
HER2-positive Breast Cancer
Brain Metastases
Interventions
First Posted Date
2021-02-18
Last Posted Date
2021-06-02
Lead Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Target Recruit Count
120
Registration Number
NCT04760431
Locations
🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

First Affiliated Hospital, Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China

🇨🇳

Peking University International Hospital, Beijing, Beijing, China

Pyrotinib as Neoadjuvant Agent for Non-objective Response HER2-positive Early Breast Cancer

First Posted Date
2021-01-22
Last Posted Date
2021-06-04
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
60
Registration Number
NCT04717531
Locations
🇨🇳

the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer

Conditions
Breast Cancer
Interventions
First Posted Date
2020-12-24
Last Posted Date
2020-12-24
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
80
Registration Number
NCT04683445
Locations
🇨🇳

Sun Yat Sen Memorial Hospital,Sun Yat sen University, Guangzhou, Guangdong, China

Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction

Phase 2
Recruiting
Conditions
Breast Cancer
Heart Failure
Interventions
First Posted Date
2020-12-23
Last Posted Date
2025-04-06
Lead Sponsor
Population Health Research Institute
Target Recruit Count
130
Registration Number
NCT04680442
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

🇧🇷

Irmandade Da Santa Casa De Misericórdia De Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

🇧🇷

Hospital Alemão Oswaldo Cruz, São Paulo, Brazil

and more 5 locations

De-escalation Adjuvant Chemo in HER2+/ER-/Node-neg Early BC Patients Who Achieved pCR After Neoadjuvant Chemo & Dual HER2 Blockade

Phase 2
Terminated
Conditions
HER2-positive Breast Cancer
ER-Negative Breast Cancer
PR-Negative Breast Cancer
Node-negative Breast Cancer
Interventions
First Posted Date
2020-12-19
Last Posted Date
2024-12-04
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
139
Registration Number
NCT04675827
Locations
🇫🇷

Institut Curie - Paris, Paris, France

🇫🇷

CH Perpignan, Perpignan, France

🇫🇷

CHU Poitiers, Poitiers, France

and more 82 locations

Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2020-11-16
Last Posted Date
2024-04-19
Lead Sponsor
Qilu Pharmaceutical Co., Ltd.
Target Recruit Count
517
Registration Number
NCT04629846
Locations
🇨🇳

Fudan University Cancer Hospital, Shanghai, Shanghai, China

🇨🇳

Tianjin Medical University Cancer Institution & Hospital, Tianjin, Tianjin, China

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

Phase 1
Recruiting
Conditions
HER2-positive Breast Cancer
Leptomeningeal Metastasis
Leptomeningeal Disease
Interventions
Radiation: Radiation Therapy
First Posted Date
2020-10-19
Last Posted Date
2025-04-17
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
39
Registration Number
NCT04588545
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

🇺🇸

Northwestern University, Evanston, Illinois, United States

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

First Posted Date
2020-10-19
Last Posted Date
2023-10-03
Lead Sponsor
Fondazione per la Medicina Personalizzata
Target Recruit Count
400
Registration Number
NCT04591431
Locations
🇮🇹

I.R.S.T. Srl Irccs, Meldola, Italy

🇮🇹

Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy

🇮🇹

I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations
© Copyright 2025. All Rights Reserved by MedPath