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 Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2013-12-24
- Last Posted Date
- 2018-09-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 50
- Registration Number
- NCT02019277
- Locations
- 🇦🇺
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
🇦🇺St George Hospital; Cancer Care Centre, Kogarah, New South Wales, Australia
🇦🇺Port Macquarie Base Hospital, Port Macquarie, New South Wales, Australia
A Study to Evaluate the Effect of the Combination of Pertuzumab With Carboplatin-Based Standard Chemotherapy in Patients With Recurrent Ovarian Cancer
- Conditions
- Ovarian Cancer
- Interventions
- First Posted Date
- 2013-12-06
- Last Posted Date
- 2014-12-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 149
- Registration Number
- NCT02004093
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
- Conditions
- HER2-Positive Breast CarcinomaStage IIB Breast Cancer AJCC v6 and v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7Hormone Receptor-Positive Breast CarcinomaStage IIIA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage IIA Breast Cancer AJCC v6 and v7
- Interventions
- Drug: Aromatase Inhibition TherapyOther: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker AnalysisOther: Quality-of-Life AssessmentProcedure: Therapeutic Conventional SurgeryRadiation: Whole Breast Irradiation
- First Posted Date
- 2013-12-06
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 315
- Registration Number
- NCT02003209
- Locations
- 🇺🇸
Fairbanks Memorial Hospital, Fairbanks, Alaska, United States
🇺🇸CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, United States
🇺🇸Kaiser Permanente-Anaheim, Anaheim, California, United States
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2013-10-21
- Last Posted Date
- 2022-06-14
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1846
- Registration Number
- NCT01966471
- Locations
- 🇨🇦
Princess Margaret Cancer Center, Toronto, Ontario, Canada
🇦🇺Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
🇯🇵Niigata Cancer Ctr Hospital; Breast Surgery, Niigata, Japan
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2013-09-09
- Last Posted Date
- 2025-03-14
- Target Recruit Count
- 88
- Registration Number
- NCT01937117
- Locations
- 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸Baylor College of Medicine, Houston, Texas, United States
🇺🇸Fred Hutchinson Cancer Research Center - University of Washington, Seattle, Washington, United States
A Study to Evaluate Lumretuzumab in Combination With Pertuzumab and Paclitaxel in Participants With Metastatic Breast Cancer Expressing Human Epidermal Growth Factor Receptor (HER) 3 and HER2 Protein
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2013-08-07
- Last Posted Date
- 2017-09-12
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 66
- Registration Number
- NCT01918254
- Locations
- 🇫🇷
Institut Curie; Oncologie Medicale, Paris, France
🇩🇪Universitaetsklinikum Essen; Westdeutsches Tumorzentrum; Innere Klinik (Tumorforschung), Essen, Germany
🇪🇸Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, Spain
Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer
- Conditions
- Metastatic Breast CancerHER2-positive Breast Cancer
- Interventions
- First Posted Date
- 2013-07-31
- Last Posted Date
- 2018-12-05
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 32
- Registration Number
- NCT01912963
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Cardiac Safety Study in Patients With HER2 + Breast Cancer
- Conditions
- HER2 Positive Breast CancerLeft Ventricular Function Systolic Dysfunction
- Interventions
- First Posted Date
- 2013-07-22
- Last Posted Date
- 2022-05-10
- Lead Sponsor
- Medstar Health Research Institute
- Target Recruit Count
- 31
- Registration Number
- NCT01904903
- Locations
- 🇺🇸
Washington Cancer Institute at MedStar Washington Hospital Center, Washington, District of Columbia, United States
🇺🇸MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib
- Conditions
- Breast Neoplasms
- Interventions
- First Posted Date
- 2013-06-12
- Last Posted Date
- 2020-09-04
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Target Recruit Count
- 26
- Registration Number
- NCT01875666
- Locations
- 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸MD Anderson, Houston, Texas, United States
Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer
- Conditions
- Her2-Positive Breast Cancer
- Interventions
- First Posted Date
- 2013-05-17
- Last Posted Date
- 2020-03-31
- Lead Sponsor
- Yale University
- Target Recruit Count
- 50
- Registration Number
- NCT01855828
- Locations
- 🇺🇸
Yale University Smilow Cancer Hospital, New Haven, Connecticut, United States
Drug Development Updates
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