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 to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2012-03-28
- Last Posted Date
- 2016-11-22
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 213
- Registration Number
- NCT01565083
A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2011-12-14
- Last Posted Date
- 2020-10-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 258
- Registration Number
- NCT01491737
- Locations
- 🇹🇷
Ankara City Hospital, Ankara, Turkey
🇺🇸Washington University School of Medicine; Internal Medicine - Renal, Saint Louis, Missouri, United States
🇺🇸Ironwood Cancer TX & Rsch Ctrs, Chandler, Arizona, United States
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
- Conditions
- Gastric Cancer
- Interventions
- First Posted Date
- 2011-10-27
- Last Posted Date
- 2018-08-09
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 30
- Registration Number
- NCT01461057
- Locations
- 🇨🇿
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, Czechia
🇧🇪UZ Leuven Gasthuisberg, Leuven, Belgium
🇮🇹Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2, Milano, Lombardia, Italy
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2011-05-24
- Last Posted Date
- 2025-01-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 4804
- Registration Number
- NCT01358877
- Locations
- 🇺🇸
Texas Oncology - DFW, Dallas, Texas, United States
🇺🇸The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc., Columbus, Ohio, United States
🇺🇸Rush University Medical Center, Chicago, Illinois, United States
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2011-01-13
- Last Posted Date
- 2020-08-03
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 70
- Registration Number
- NCT01276041
- Locations
- 🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
🇺🇸Memorial Sloan Kettering West Harrison, Harrison, New York, United States
Combination of Bevacizumab, Pertuzumab, and Sandostatin for Adv. Neuroendocrine Cancers
- Conditions
- Neuroendocrine Carcinoma
- Interventions
- First Posted Date
- 2010-05-12
- Last Posted Date
- 2016-02-05
- Lead Sponsor
- SCRI Development Innovations, LLC
- Target Recruit Count
- 43
- Registration Number
- NCT01121939
- Locations
- 🇺🇸
Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey, United States
🇺🇸Florida Hospital Cancer Institute, Orlando, Florida, United States
🇺🇸Grand Rapids Oncology Program, Grand Rapids, Michigan, United States
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2010-05-10
- Last Posted Date
- 2024-03-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1095
- Registration Number
- NCT01120184
- Locations
- 🇹🇭
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, Thailand
🇹🇷Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara, Turkey
🇬🇧Bristol Haematology and Oncology centre, Bristol, United Kingdom
A Phase 2 Study of Pertuzumab and Erlotinib for Refractory Pancreatic Adenocarcinoma
- First Posted Date
- 2010-04-22
- Last Posted Date
- 2017-03-03
- Lead Sponsor
- George Albert Fisher
- Target Recruit Count
- 1
- Registration Number
- NCT01108458
- Locations
- 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- First Posted Date
- 2010-01-13
- Last Posted Date
- 2016-01-29
- Lead Sponsor
- SCRI Development Innovations, LLC
- Target Recruit Count
- 283
- Registration Number
- NCT01048099
- Locations
- 🇺🇸
Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
🇺🇸Florida Cancer Specialists, St. Petersburg, Florida, United States
🇺🇸Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
- Conditions
- HER2-negative Breast CancerHormone Receptor Positive TumorAngiosarcomaTNBC - Triple-Negative Breast CancerBreast NeoplasmsBreast TumorsHER2-positive Breast CancerHormone Receptor Negative TumorBreast CancerEarly-stage Breast Cancer
- Interventions
- Drug: Standard TherapyDrug: AMG 386 with or without TrastuzumabDrug: AMG 479 (Ganitumab) plus MetforminDrug: SYD985 ([vic-]trastuzumab duocarmazine)Drug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) + Carboplatin with or without trastuzumabDrug: Oral Paclitaxel + Encequidar + Dostarlimab (TSR-042) with or without trastuzumabDrug: Datopotamab deruxtecan + DurvalumabDrug: Rilvegostomig + TDXdDrug: AMG 386 and Trastuzumab
- First Posted Date
- 2010-01-05
- Last Posted Date
- 2024-10-22
- Lead Sponsor
- QuantumLeap Healthcare Collaborative
- Target Recruit Count
- 5000
- Registration Number
- NCT01042379
- Locations
- 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸University of Texas, Southwestern Medical Center, Dallas, Texas, United States
🇺🇸University of Kansas, Westwood, Kansas, United States
Drug Development Updates
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