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

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

Phase 2
Active, not recruiting
Conditions
Invasive Breast Carcinoma
Prognostic Stage IIA Breast Cancer AJCC v8
Prognostic Stage IIB Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Prognostic Stage II Breast Cancer AJCC v8
Prognostic Stage IIIA Breast Cancer AJCC v8
Interventions
First Posted Date
2020-02-12
Last Posted Date
2025-04-18
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
2175
Registration Number
NCT04266249
Locations
🇺🇸

Mercy Cancer Center-West Lakes, Clive, Iowa, United States

🇺🇸

Essentia Health Cancer Center, Duluth, Minnesota, United States

🇺🇸

Ann M Wierman MD LTD, Las Vegas, Nevada, United States

and more 1000 locations

Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients

Phase 1
Recruiting
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2020-02-05
Last Posted Date
2023-04-18
Lead Sponsor
SOLTI Breast Cancer Research Group
Target Recruit Count
15
Registration Number
NCT04253561
Locations
🇪🇸

ICO Badalona, Badalona, Barcelona, Spain

🇪🇸

Comp. Hosp.Univ. Santiago (Chus), Santiago De Compostela, La Coruña, Spain

🇪🇸

Hospital Universitario del Vall d' Hebron, Barcelona, Spain

and more 7 locations

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Phase 3
Active, not recruiting
Conditions
Advanced HER2+Breast Cancer
Interventions
First Posted Date
2019-12-23
Last Posted Date
2025-05-13
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
19
Registration Number
NCT04208178
Locations
🇺🇸

Highlands Oncology Group, Fayetteville, Arkansas, United States

🇺🇸

University of California LA, Los Angeles, California, United States

🇪🇸

Novartis Investigative Site, Hospitalet de LLobregat, Catalunya, Spain

Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer

First Posted Date
2019-12-10
Last Posted Date
2020-03-09
Lead Sponsor
Fudan University
Target Recruit Count
1560
Registration Number
NCT04193059
Locations
🇨🇳

Cancer Hospital Affiliated to Fudan University, Shanghai, Shanghai, China

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Phase 1
Active, not recruiting
Conditions
Metastatic Breast Cancer
Breast Cancer
Advanced Breast Cancer
Endometrial Cancer
Interventions
First Posted Date
2019-12-06
Last Posted Date
2025-04-17
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
500
Registration Number
NCT04188548
Locations
🇺🇸

Winship Cancer Center Emory University, Atlanta, Georgia, United States

🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

and more 69 locations

ACHP-THP vs EC-THP as Neoadjuvant Therapy for HER2-positive EBC

Phase 2
Active, not recruiting
Conditions
Breast Cancer
Neoadjuvant Chemotherapy
Interventions
First Posted Date
2019-11-21
Last Posted Date
2023-10-16
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
156
Registration Number
NCT04172259
Locations
🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

A Study to Describe the Diagnosis, Anti-Cancer Treatment and Clinical Outcome in Patients With Newly Diagnosed Breast Cancer in Latin America

First Posted Date
2019-11-08
Last Posted Date
2025-05-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
2907
Registration Number
NCT04158258
Locations
🇧🇷

Instituto Brasileiro De Controle Do Câncer - IBCC, São Paulo, Brazil

🇦🇷

Sanatorio de la Mujer, Rosario, Argentina

🇧🇷

Hospital Jardim Amália, Volta Redonda, Rio De Janeiro, Brazil

and more 27 locations

A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer

Phase 3
Active, not recruiting
Conditions
HER2-positive Early Breast Cancer
Interventions
First Posted Date
2019-07-18
Last Posted Date
2025-03-13
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
200
Registration Number
NCT04024462
Locations
🇨🇳

Jilin Cancer Hospital, Changchun, China

🇨🇳

West China Hospital, Sichuan University, Chengdu, China

🇨🇳

The 900th Hospital of PLA joint service support force, Fuzhou, China

and more 15 locations

A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1)

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2019-06-17
Last Posted Date
2023-05-15
Lead Sponsor
West German Study Group
Target Recruit Count
46
Registration Number
NCT03988036
Locations
🇩🇪

Niels-Stensen-Kliniken Franziskus-Hospital Harderberg Zentrum für Frauenheilkunde und Abteilung für Senologie, Georgsmarienhütte, Lower Saxony, Germany

🇩🇪

Mammazentrum Hamburg, Hamburg, Germany

🇩🇪

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Bavaria, Germany

and more 9 locations

Improving Pre-operative Systemic Therapy for Human Epidermal Growth Factor Receptor 2 (HER2) Amplified Breast Cancer

First Posted Date
2019-03-28
Last Posted Date
2021-09-23
Lead Sponsor
Renske Altena
Target Recruit Count
6
Registration Number
NCT03894007
Locations
🇸🇪

Sahlgrenska universitetssjukhuset, Göteborg, Sweden

🇸🇪

Skånes universitetssjukhus, Malmö, Sweden

🇸🇪

Länssjukhuset Sundsvall, Sundsvall, Sweden

and more 5 locations
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