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

Her2-positive Lung Cancer Treated With Dedicated Drug

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer Metastatic
HER2 Gene Mutation
Non Small Cell Lung Cancer Stage III
Interventions
First Posted Date
2019-02-19
Last Posted Date
2023-12-19
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
46
Registration Number
NCT03845270
Locations
🇫🇷

Montpellier - CHRU, Montpellier, France

🇫🇷

Centre Hospitalier - Pneumologie, Le Mans, France

🇫🇷

Hôpital Nord APHM, Marseille, France

and more 15 locations

Durvalumab with Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2019-01-29
Last Posted Date
2025-03-10
Lead Sponsor
The Methodist Hospital Research Institute
Target Recruit Count
39
Registration Number
NCT03820141
Locations
🇺🇸

Houston Methodist Cancer Center, Houston, Texas, United States

A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

Phase 3
Withdrawn
Conditions
Advanced Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2019-01-22
Last Posted Date
2019-11-26
Lead Sponsor
iOMEDICO AG
Registration Number
NCT03811418
Locations
🇩🇪

iOMEDICO AG, Freiburg, Baden-Wuerttemberg, Germany

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

Phase 2
Active, not recruiting
Conditions
Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2018-11-20
Last Posted Date
2025-05-08
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
138
Registration Number
NCT03747120
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

🇺🇸

New Mexico Cancer Center, Albuquerque, New Mexico, United States

and more 2 locations

Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

First Posted Date
2018-11-15
Last Posted Date
2023-12-19
Lead Sponsor
NYU Langone Health
Target Recruit Count
8
Registration Number
NCT03742986
Locations
🇺🇸

Indiana University, Bloomington, Indiana, United States

🇺🇸

NYU Langone Health, New York, New York, United States

A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer

First Posted Date
2018-11-01
Last Posted Date
2024-11-05
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
454
Registration Number
NCT03726879
Locations
🇺🇸

Tennessee Oncology - Nashville, Nashville, Tennessee, United States

🇺🇸

HCA Midwest Division, Kansas City, Missouri, United States

🇺🇸

New York University Medical Center PRIME; NYU Langone Medical Center, New York, New York, United States

and more 73 locations

DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC

Phase 1
Active, not recruiting
Conditions
Breast Cancer
Interventions
First Posted Date
2018-10-23
Last Posted Date
2023-09-07
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
100
Registration Number
NCT03716180
Locations
🇺🇸

DF/BWCC in clinical affiliation with South Shore Hospital, South Weymouth, Massachusetts, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 2 locations

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

First Posted Date
2018-09-17
Last Posted Date
2024-01-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
160
Registration Number
NCT03674112
Locations
🇺🇸

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

🇺🇸

Texas Oncology - Memorial City, Houston, Texas, United States

🇨🇺

Hospital Hermanos Ameijeiras, La Habana, Cuba

and more 37 locations

To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)

Phase 2
Completed
Conditions
Estrogen Receptor Positive Tumor
Breast Cancer
HER2-positive Breast Cancer
Interventions
First Posted Date
2018-08-23
Last Posted Date
2024-12-13
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
147
Registration Number
NCT03644186
Locations
🇫🇷

Institut Bergonié, Bordeaux, France

🇫🇷

Centre Léon Berard, Lyon, France

🇮🇹

Centro di Riferimento Oncologico (CRO), Via Franco Gallini 2, Aviano, Pordenone, Italy

and more 51 locations

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
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