Pertuzumab

Generic Name
Pertuzumab
Brand Names
Perjeta, Perjeta-Herceptin, Phesgo
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

First Posted Date
2011-10-27
Last Posted Date
2018-08-09
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
30
Registration Number
NCT01461057
Locations
🇨🇿

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, Czechia

🇧🇪

UZ Leuven Gasthuisberg, Leuven, Belgium

🇮🇹

Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy

and more 21 locations

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

First Posted Date
2011-05-24
Last Posted Date
2024-06-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
4804
Registration Number
NCT01358877
Locations
🇺🇸

Texas Oncology - DFW, Dallas, Texas, United States

🇺🇸

The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 552 locations

Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers

First Posted Date
2010-05-12
Last Posted Date
2016-02-05
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
43
Registration Number
NCT01121939
Locations
🇺🇸

Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey, United States

🇺🇸

Florida Hospital Cancer Institute, Orlando, Florida, United States

🇺🇸

Grand Rapids Oncology Program, Grand Rapids, Michigan, United States

and more 6 locations

A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

First Posted Date
2010-05-10
Last Posted Date
2024-03-04
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
1095
Registration Number
NCT01120184
Locations
🇹🇭

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, Thailand

🇹🇷

Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara, Turkey

🇬🇧

Bristol Haematology and Oncology centre, Bristol, United Kingdom

and more 254 locations

A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2010-04-22
Last Posted Date
2017-03-03
Lead Sponsor
George Albert Fisher
Target Recruit Count
1
Registration Number
NCT01108458
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer

First Posted Date
2010-01-13
Last Posted Date
2016-01-29
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
283
Registration Number
NCT01048099
Locations
🇺🇸

Center for Cancer and Blood Disorders, Fort Worth, Texas, United States

🇺🇸

Florida Cancer Specialists, St. Petersburg, Florida, United States

🇺🇸

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States

and more 3 locations

A Study of a Combination of Trastuzumab and Capecitabine With or Without Pertuzumab in Patients With HER2-positive Metastatic Breast Cancer (PHEREXA)

First Posted Date
2009-12-04
Last Posted Date
2018-08-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
452
Registration Number
NCT01026142
Locations
🇧🇪

UZ Brussel, Brussel, Belgium

🇭🇰

Queen Mary Hospital; Surgery, Hong Kong, Hong Kong

🇷🇺

Semashko Central Clinical Hospital; Dept of Chemotherapy, Moscow, Russian Federation

and more 187 locations

A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer

First Posted Date
2009-09-15
Last Posted Date
2017-02-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
225
Registration Number
NCT00976989

A Phase II Study of Pertuzumab and Erlotinib for Metastatic or Unresectable Neuroendocrine Tumors

First Posted Date
2009-07-27
Last Posted Date
2017-03-03
Lead Sponsor
Pamela L. Kunz
Target Recruit Count
4
Registration Number
NCT00947167
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Participants With Advanced Breast Cancer

First Posted Date
2009-07-08
Last Posted Date
2017-04-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
98
Registration Number
NCT00934856
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