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

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-06-04
Last Posted Date
2024-07-11
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
28
Registration Number
NCT06441890
Locations
🇺🇸

University of Illinois, Chicago, Illinois, United States

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Phase 2
Recruiting
Conditions
Stage IV Breast Cancer
Breast Cancer Metastatic
Breast Cancer Female
Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2024-06-03
Last Posted Date
2025-04-03
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
72
Registration Number
NCT06439693
Locations
🇺🇸

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

Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery

Phase 2
Not yet recruiting
Conditions
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
HER2-positive Breast Cancer
Breast Cancer
Interventions
First Posted Date
2024-04-04
Last Posted Date
2025-05-06
Lead Sponsor
University of Chicago
Target Recruit Count
74
Registration Number
NCT06348134
Locations
🇳🇬

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife, Osun, Nigeria

🇺🇸

University of Chicago, Chicago, Illinois, United States

Disitamab Vedotin + Pyrotinib Versus THP in the First-line Treatment for HER2+ Advanced Breast Cancer Clinical Trial

Phase 3
Recruiting
Conditions
First-line Treatment
HER2-positive Metastatic Breast Cancer
Interventions
First Posted Date
2024-02-26
Last Posted Date
2024-02-26
Lead Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Target Recruit Count
312
Registration Number
NCT06278870
Locations
🇨🇳

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

DV in Combination With Pertuzumab With or Without Toripalimab Neoadjuvant Therapy With HER2-positive Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2023-12-20
Last Posted Date
2024-02-20
Lead Sponsor
RemeGen Co., Ltd.
Target Recruit Count
80
Registration Number
NCT06178159
Locations
🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

Phase 1
Recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2023-12-08
Last Posted Date
2024-01-11
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
30
Registration Number
NCT06162559
Locations
🇳🇱

Netherlands Cancer Institute, Amsterdam, Netherlands

Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J)

Phase 2
Active, not recruiting
Conditions
Malignant Solid Neoplasm
Interventions
Procedure: Biopsy
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Echocardiography
Procedure: Echocardiography Test
Biological: Pertuzumab
Procedure: Radiologic Examination
Biological: Trastuzumab
First Posted Date
2023-11-18
Last Posted Date
2025-05-16
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
35
Registration Number
NCT06136897
Locations
🇺🇸

ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer

Phase 3
Not yet recruiting
Conditions
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Interventions
Biological: PERT-IJS plus trastuzumab, carboplatin and docetaxel
First Posted Date
2023-09-15
Last Posted Date
2024-12-17
Lead Sponsor
Biocon Biologics UK Ltd
Target Recruit Count
382
Registration Number
NCT06038539

Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.

Phase 3
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
Drug: TQB2440 injection + Trastuzumab + Docetaxel
First Posted Date
2023-08-14
Last Posted Date
2023-08-14
Lead Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Target Recruit Count
412
Registration Number
NCT05985187
Locations
🇨🇳

The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, China

🇨🇳

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

🇨🇳

Affiliated cancer hospital of harbin medical university, Harbin, Heilongjiang, China

and more 3 locations

Study of Utidelone Based Neoadjuvant Treatment on Early High-risk or Locally Advanced Breast Cancer

Phase 2
Not yet recruiting
Conditions
Breast Cancer
Neoadjuvant Therapy
Interventions
First Posted Date
2023-08-09
Last Posted Date
2023-08-09
Lead Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Target Recruit Count
181
Registration Number
NCT05983094
Locations
🇨🇳

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

© Copyright 2025. All Rights Reserved by MedPath