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 Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

Phase 1
Recruiting
Conditions
HER2-positive Advanced Solid Tumor
Interventions
First Posted Date
2021-12-09
Last Posted Date
2025-04-09
Lead Sponsor
DualityBio Inc.
Target Recruit Count
796
Registration Number
NCT05150691
Locations
🇺🇸

TOI Clinical Research, Cerritos, California, United States

🇺🇸

California Research Institute, Los Angeles, California, United States

🇺🇸

Sharp Memorial Hospital, San Diego, California, United States

and more 86 locations

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

Phase 3
Active, not recruiting
Conditions
HER2 Positive Breast Cancer
Interventions
First Posted Date
2021-11-24
Last Posted Date
2025-05-20
Lead Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Target Recruit Count
650
Registration Number
NCT05132582
Locations
🇨🇱

James Lind Centro De Investigacion Del Cancer, Temuco, Chile

🇨🇳

The Second Hospital of Anhui Medical University, Hefei City, Anhui, China

🇩🇪

Universitatsklinikum Wurzburg Apotheke, Wurzburg, Germany

and more 377 locations

Neoadjuvant Treatment of Breast Cancer

First Posted Date
2021-11-23
Last Posted Date
2021-11-23
Lead Sponsor
National Institute of Oncology, Hungary
Target Recruit Count
300
Registration Number
NCT05131893
Locations
🇭🇺

National Institute of Oncolgy, Budapest, Hungary

Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer

Phase 3
Active, not recruiting
Conditions
Breast Neoplasms
HER2-positive Early Breast Cancer
Breast Cancer
Interventions
First Posted Date
2021-11-09
Last Posted Date
2025-05-06
Lead Sponsor
AstraZeneca
Target Recruit Count
927
Registration Number
NCT05113251
Locations
🇹🇭

Research Site, Khon Kaen, Thailand

Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

Phase 2
Active, not recruiting
Conditions
Metastatic Breast Cancer With a Isolated Brain Progression
Interventions
First Posted Date
2021-09-13
Last Posted Date
2024-10-17
Lead Sponsor
UNICANCER
Target Recruit Count
53
Registration Number
NCT05041842
Locations
🇫🇷

Institut de Cancérologie de l'Ouest - Site Paul Papin, Angers, France

🇫🇷

Centre Francois Baclesse, Caen, France

🇫🇷

Centre Georges François Leclerc, Dijon, France

and more 12 locations

Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON)

Phase 4
Recruiting
Conditions
Breast Cancer
Breast Neoplasms
Breast Cancer Female
HER2-positive Breast Cancer
Interventions
First Posted Date
2021-09-05
Last Posted Date
2023-04-18
Lead Sponsor
Institut fuer Frauengesundheit
Target Recruit Count
108
Registration Number
NCT05036005
Locations
🇩🇪

Department of Gynecology and Obstetrics, Dresden University Hospital Carl-Gustav Carus, Dresden, Saxony, Germany

🇩🇪

Department for Gynecology and Obstetrics, Marienhospital Bottrop gGmbH, Bottrop, North Rhine-Westphalia, Germany

🇩🇪

Department for Hematology, Oncology and Tumor Immunology Charité Campus Benjamin Franklin, Berlin, Germany

and more 8 locations

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Phase 2
Recruiting
Conditions
Breast Cancer
Breast Neoplasm
Breast Cancer Invasive
Breast Cancer Female
Breast Cancer Stage II
Breast Cancer Stage III
Hormone Receptor-positive Breast Cancer
HER2-positive Breast Cancer
Triple Negative Breast Neoplasms
Estrogen Receptor-positive Breast Cancer
Interventions
First Posted Date
2021-08-25
Last Posted Date
2025-02-27
Lead Sponsor
Baylor Breast Care Center
Target Recruit Count
185
Registration Number
NCT05020860
Locations
🇺🇸

Harris Health System - Smith Clinic, Houston, Texas, United States

🇺🇸

O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States

Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

Phase 2
Recruiting
Conditions
Circulating Tumor Cell
Breast Neoplasms
HER2-positive Breast Cancer
Interventions
Other: Circulating tumor cells
First Posted Date
2021-08-06
Last Posted Date
2021-08-06
Lead Sponsor
AC Camargo Cancer Center
Target Recruit Count
80
Registration Number
NCT04993014
Locations
🇧🇷

A.C. Camargo Cancer Center, São Paulo, Brazil

Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer

Phase 3
Completed
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2021-07-12
Last Posted Date
2024-07-26
Lead Sponsor
Cinnagen
Target Recruit Count
214
Registration Number
NCT04957212
Locations
🇮🇷

Qaem Hospital, Mashhad, Khorasan Razavi, Iran, Islamic Republic of

🇮🇷

Amir Hospital, Shiraz, Iran, Islamic Republic of

🇮🇷

Shahid Faghihi Hospital, Shiraz, Iran, Islamic Republic of

and more 41 locations

Pyrotinib Versus Pertuzumab in Combination With Neoadjuvant Trastuzumab and Nab-Paclitaxel in HER2+ Early or Locally Advanced Breast Cancer

Phase 2
Not yet recruiting
Conditions
HER2+ Early or Locally Advanced Breast Cancer
Interventions
First Posted Date
2021-05-25
Last Posted Date
2021-05-25
Lead Sponsor
Tianjin Medical University Cancer Institute and Hospital
Target Recruit Count
490
Registration Number
NCT04900311
© Copyright 2025. All Rights Reserved by MedPath