Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study

A subcutaneous formulation of pertuzumab and trastuzumab with recombinant human hyaluronidase in one ready-to-use, fixed-dose combination vial (pertuzumab, trastuzumab, and hyaluronidase-zzxf) was approved by the US Food and Drug Administration (FDA) on June 29, 2020. We report the primary analysis...

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Veröffentlicht in:	The lancet oncology 2021-01, Vol.22 (1), p.85-97
Hauptverfasser:	Tan, Antoinette R, Im, Seock-Ah, Mattar, André, Colomer, Ramon, Stroyakovskii, Daniil, Nowecki, Zbigniew, De Laurentiis, Michelino, Pierga, Jean-Yves, Jung, Kyung Hae, Schem, Christian, Hogea, Alexandra, Badovinac Crnjevic, Tanja, Heeson, Sarah, Shivhare, Mahesh, Kirschbrown, Whitney P, Restuccia, Eleonora, Jackisch, Christian
Format:	Artikel
Sprache:	eng
Schlagworte:	Adult Antibodies, Monoclonal, Humanized - administration & dosage Antibodies, Monoclonal, Humanized - adverse effects Antibodies, Monoclonal, Humanized - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics Antineoplastic Combined Chemotherapy Protocols - therapeutic use Biomarkers, Tumor - analysis Breast cancer Breast Neoplasms - chemistry Breast Neoplasms - drug therapy Breast Neoplasms - mortality Breast Neoplasms - pathology Cancer therapies Chemotherapy Chemotherapy, Adjuvant Clinical trials Diarrhea Drug therapy ErbB-2 protein FDA approval Female Heart Humans Hyaluronoglucosaminidase - administration & dosage Immunotherapy Inflammation Injection Injections, Subcutaneous Intravenous administration Mammography Metastasis Middle Aged Monoclonal antibodies Myocardial infarction Neoadjuvant Therapy Neoplasm Staging Neutropenia Oncology Patients Pharmacokinetics Receptor, ErbB-2 - analysis Safety Surgery Targeted cancer therapy Time Factors Trastuzumab Trastuzumab - administration & dosage Trastuzumab - adverse effects Trastuzumab - pharmacokinetics Treatment Outcome Ventricle
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