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

Phase 3
Completed
Conditions
Breast Cancer
Interventions
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

Phase 2
Completed
Conditions
Breast Cancer
Interventions
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 Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2009-08-04
Last Posted Date
2016-06-24
Lead Sponsor
Genentech, Inc.
Target Recruit Count
107
Registration Number
NCT00951665

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

Phase 2
Terminated
Conditions
Adrenal Gland Tumors
Carcinoid Tumors
Neuroblastoma
Multiple Endocrine Neoplasia
Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumors
Interventions
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

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2009-07-08
Last Posted Date
2017-04-06
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
98
Registration Number
NCT00934856

A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer

Phase 2
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2009-03-05
Last Posted Date
2013-05-21
Lead Sponsor
Genentech, Inc.
Target Recruit Count
41
Registration Number
NCT00855894

A Study of Pregnancy and Pregnancy Outcomes in Women With Breast Cancer Treated With Trastuzumab, Pertuzumab in Combination With Trastuzumab, or Ado-Trastuzumab Emtansine

Completed
Conditions
Breast Cancer
Pregnancy
Interventions
First Posted Date
2009-02-02
Last Posted Date
2019-05-16
Lead Sponsor
Genentech, Inc.
Target Recruit Count
20
Registration Number
NCT00833963
Locations
🇺🇸

Kendle International, Inc, Wilmington, North Carolina, United States

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

First Posted Date
2008-10-29
Last Posted Date
2025-04-04
Lead Sponsor
Genentech, Inc.
Target Recruit Count
720
Registration Number
NCT00781612
Locations
🇩🇪

Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche, Berlin, Germany

🇩🇪

HELIOS Klinikum Berlin-Buch, Berlin, Germany

🇩🇪

Rotkreuzklinikum München, Muenchen, Germany

and more 175 locations

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

Phase 3
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2007-12-04
Last Posted Date
2019-12-13
Lead Sponsor
Genentech, Inc.
Target Recruit Count
808
Registration Number
NCT00567190
Locations
🇺🇸

UCLA, Los Angeles, California, United States

🇺🇸

LAC USC Medical Center, Los Angeles, California, United States

🇺🇸

St. Barnabas Cancer Center, Livingston, New Jersey, United States

and more 312 locations
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