MedPath

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
-

Neoadjuvant Treatment of HER2 Positive Early High-risk and Locally Advanced Breast Cancer

Phase 3
Active, not recruiting
Conditions
Invasive Breast Cancer
Interventions
First Posted Date
2018-07-23
Last Posted Date
2024-03-06
Lead Sponsor
Fondazione Michelangelo
Target Recruit Count
650
Registration Number
NCT03595592
Locations
🇪🇸

MD Anderson Cancer Center, Madrid, Spain

🇪🇸

Hospital Virgen de la Nieves, Granada, Spain

🇮🇹

Ospedale Santa Maria della Misericordia, Udine, Italy

and more 62 locations

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

First Posted Date
2018-04-13
Last Posted Date
2024-06-14
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
528
Registration Number
NCT03498521
Locations
🇦🇺

Northern Cancer Institute, St Leonards, New South Wales, Australia

🇦🇺

Blacktown Hospital, Blacktown, New South Wales, Australia

🇫🇮

Helsinki University Central Hospital; Dept of Oncology, Helsinki, Finland

and more 134 locations

Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC

Phase 2
Active, not recruiting
Conditions
Central Nervous System Metastases
HER2-positive Metastatic Breast Cancer
Interventions
First Posted Date
2018-01-31
Last Posted Date
2024-07-05
Lead Sponsor
Nancy Lin, MD
Target Recruit Count
19
Registration Number
NCT03417544
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

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

Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling

Phase 2
Recruiting
Conditions
HER2-negative Breast Cancer
Interventions
First Posted Date
2018-01-26
Last Posted Date
2023-03-06
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
64
Registration Number
NCT03412643
Locations
🇺🇸

Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States

🇺🇸

Fort Wayne Medical Oncology and Hematology, Inc., Fort Wayne, Indiana, United States

🇺🇸

Greater Baltimore Medical Center, Baltimore, Maryland, United States

and more 40 locations

Neoadjuvant Dose-Dense For Early Her2Neu Positive Breast Cancer

First Posted Date
2017-11-06
Last Posted Date
2023-08-22
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
7
Registration Number
NCT03329378
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

🇺🇸

Mount Sinai Beth Israel, New York, New York, United States

🇺🇸

Mount Sinai West, New York, New York, United States

Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast

Phase 1
Active, not recruiting
Conditions
Breast Neoplasms
Breast Diseases
Interventions
First Posted Date
2017-10-06
Last Posted Date
2024-08-01
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
44
Registration Number
NCT03304080
Locations
🇺🇸

Perlmutter Cancer Center NYU Langone, New York, New York, United States

🇺🇸

New York Presbyterian Weill Cornell Medical Center, New York, New York, United States

🇺🇸

New York Presbyterian Columbia Irving Comprehensive Cancer Center, New York, New York, United States

and more 2 locations

A Study to Compare Eribulin Mesylate + Pertuzumab + Trastuzumab With Paclitaxel or Docetaxel + Pertuzumab + Trastuzumab

First Posted Date
2017-08-29
Last Posted Date
2017-09-21
Lead Sponsor
Japan Breast Cancer Research Group
Target Recruit Count
480
Registration Number
NCT03264547
Locations
🇯🇵

National Hospital Organization Osaka National Hospital, Ōsaka, Osaka, Japan

🇯🇵

Kanagawa Cancer Center, Yokohama, Kanagawa, Japan

Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer

Phase 3
Active, not recruiting
Conditions
Unresectable HER2-Positive Breast Carcinoma
Stage III Breast Cancer AJCC v7
Stage IV Breast Cancer AJCC v6 and v7
Metastatic Breast Adenocarcinoma
Metastatic HER2-Positive Breast Carcinoma
Recurrent Breast Adenocarcinoma
Recurrent HER2-Positive Breast Carcinoma
Unresectable Breast Carcinoma
Interventions
Drug: Atezolizumab
Procedure: Biopsy
Procedure: Bone Scan
Procedure: Computed Tomography
Drug: Docetaxel
Procedure: Magnetic Resonance Imaging
Drug: Paclitaxel
Other: Placebo Administration
Biological: Pertuzumab
Other: Quality-of-Life Assessment
Biological: Trastuzumab
First Posted Date
2017-06-27
Last Posted Date
2024-08-23
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
190
Registration Number
NCT03199885
Locations
🇺🇸

Good Samaritan Hospital - Cancer Centers of Colorado, Lafayette, Colorado, United States

🇺🇸

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

🇺🇸

Intermountain Health Lutheran Hospital, Wheat Ridge, Colorado, United States

and more 669 locations

Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2017-05-01
Last Posted Date
2021-09-10
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
11
Registration Number
NCT03135171
Locations
🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

Yale University, New Haven, New York, United States

🇺🇸

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Phase 2
Active, not recruiting
Conditions
HER2-positive Breast Cancer
Interventions
First Posted Date
2017-04-24
Last Posted Date
2025-01-10
Lead Sponsor
Fox Chase Cancer Center
Target Recruit Count
16
Registration Number
NCT03125928
Locations
🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

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