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KURZPROTOKOLL LILAC
KURZPROTOKOLL LILAC Öffentlicher Titel Phase-III Studie mit ABP 980 bei HER2-positivem Brustkrebs Wissenschaftl. Titel Efficacy and Safety Study of ABP 980 Compared With Trastuzumab in Subjects With HER2 Positive Early Breast Cancer (Lilac) Kurztitel LILAC Studienart multizentrisch, prospektiv, randomisiert, Pharma-Studie, doppelblind, zweiarmig Studienphase Phase III Erkrankung GYN: Brustkrebs: Adjuvant Einschlusskriterien - Females 18 years of age - Histologically confirmed invasive breast cancer - Planning for surgical resection of breast tumor and sentinel node or axillary lymph node resection - Planning neoadjuvant chemotherapy - HER2 positive disease - Measurable disease in the breast after diagnostic biopsy, defined as longest diameter >= 2.0 cm - Known Estrogen Receptor (ER)and Progesterone Receptor (PR) hormone receptor status at study entry - Normal bone marrow function - Normal hepatic function - Normal renal function - Subjects must sign an Institutional Review Board/Ethics Committee (IRB/EC)approved informed consent form before any study specific procedures - Bilateral breast cancer - Presence of known metastases - Received prior treatment, including chemotherapy, biologic therapy, radiation or surgery with the exception of diagnostic biopsy for primary breast cancer - Other concomitant active malignancy or history of malignancy in the past 5 years except treated basal cell carcinoma of the skin or carcinoma in situ of the cervix - Pre-existing clinically significant (>= grade 2) peripheral neuropathy - Any history of documented or current congestive heart failure, current high-risk uncontrolled arrhythmias, current angina pectoris requiring a medicinal product, current clinically significant valvular disease, current evidence of transmural infarction on electrocardiogram (ECG), or current poorly controlled hypertension - Severe dyspnea at rest requiring supplementary oxygen therapy - History of positivity for hepatitis B surface antigen, hepatitis C virus, or HIV - Recent infection requiring a course of systemic anti-infectives that were completed <= 14 days before enrollment (with the exception of uncomplicated urinary tract infection) - Woman of childbearing potential who is pregnant or is breast feeding - Woman of childbearing potential who is not consenting to use highly effective methods of birth control (eg, abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) during treatment and for an additional 4 months after the last administration of the protocol specified treatment - Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study - Other investigational procedures while participating in this study are excluded Ausschlusskriterien © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 20.01.2017; Seite 1 von 2 KURZPROTOKOLL LILAC - Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products, trastuzumab, murine proteins, or to any of the excipients - Subject previously has enrolled and/or has been randomized in this study - Subject likely to not be available to complete all protocol required study visits or procedures - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Alter 18 Jahre und älter Molekularer Marker HER2/neu pos. Status Rekrutierung beendet Beginn der Rekrutierung 01.07.2013 Prüfzentren Universitätsklinikum Frankfurt Klinik für Frauenheilkunde und Geburtshilfe Theodor-Stern-Kai 7 60590 Frankfurt am Main Dr. Stefan Marcel Loitsch Tel: 069 6301-6850 Fax: 069 6301-7938 [email protected] Dr. med. Benjamin Schnappauf Tel: 069 6301-0 Fax: 069 6301-6301 [email protected] Sponsoren AMGEN GmbH Förderer AMGEN GmbH Registrierung in anderen Studienregistern ClinicalTrials NCT01901146 EUDRACT 2012-004319-29 Therapie ABP 980 (Trastuzumab Biosimilar) © Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de Stand: 20.01.2017; Seite 2 von 2
