Last updated on April 2018

IMP321 as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma


Brief description of study

The proposed Phase IIb clinical study aims to investigate the safety and efficacy of the active immunotherapy IMP321 in combination (adjunctive) with paclitaxel chemotherapy in patients with hormone receptor-positive metastatic breast cancer.

Detailed Study Description

This is a multicentre, placebo-controlled, double-blind, 1:1 randomised Phase IIb study in female hormone receptor-positive metastatic breast cancer patients. The study comprises of two stages.

Stage 1 is the open-label, safety run-in stage consisting of cohort 1 and 2 to confirm the (RPTD) of IMP321 in combination with paclitaxel.

Stage 2 is placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo.

Clinical Study Identifier: NCT02614833

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AZ Sint-Jan Burgge-Oostende
Brugge, Belgium
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Cliniques universitaires Saint-Luc - Institut Roi Albert II - Canc rologie et H matologie Oncologie clinique
Brussel, Belgium
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AZ Sint-Maarten
Duffel, Belgium
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Universitair Ziekenhuis Antwerpen Breast and Gynecological Oncology Unit
Edegem, Belgium
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UZ Leuven, campus Gasthuisberg Department of General Medical Oncology and Multidisciplinary Breast Centre
Leuven, Belgium
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Clinique Sainte-Elisabeth
Namur, Belgium
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GZA Ziekenhuizen campus Sint-Augustinus Oncologische Research
Wilrijk, Belgium
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Institut de Canc rologie de la Loire
Saint Priest en Jarez, France
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Institut Curie / Centre Ren Huguenin
Saint-Cloud, France
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Institut Claudius Regaud - IUC Toulouse - Oncop le
Toulouse Cedex 9, France
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HELIOS Klinikum Berlin-Buch Gynecologic Oncology and Obstetrics, Head of the Interdisciplinary, Breast Cancer Center
Berlin, Germany
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KEM- Brustzentrum der Kliniken Essen-Mitte
Essen, Germany
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Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus Centrum f r H matologie und Onkologie
Frankfurt, Germany
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NCT - Nationales Centrum f r Tumorerkrankungen
Heidelberg, Germany
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UFU - Universit tsfrauenklinik Ulm
Ulm, Germany
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Szent Margit K rh z Onkol giai Oszt ly
Budapest, Hungary
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MH Eg szs g gyi K zpont Onkol giai Oszt ly
Budapest, Hungary
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DE KK Onkol giai Klinika
Debrecen, Hungary
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VU University Medical Center
Amsterdam, Netherlands
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Reinier de Graaf Gasthuis
Delft, Netherlands
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Zuyderland MC
Geleen, Netherlands
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UMCG Medisch Centrum Groningen
Groningen, Netherlands
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MUMC Medical Oncology department
Maastricht, Netherlands
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Erasmus MC
Rotterdam, Netherlands
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VieCuri Medisch Centrum
Venlo, Netherlands
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Kierownik Oddzia u Onkologii i Radioterapii Szpital Morski im. PCK w Gdyni
Gdynia, Poland
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University Centre for Ophthalmology and Oncology
Katowice, Poland
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Specjalistyczna Praktyka
Warsaw, Poland
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Military Institute of Medicine, Oncology Dept
Warsaw, Poland
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The Christie NHS Foundation Trust The Christie Clinic - Medical Oncology
Manchester, United Kingdom
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Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
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St James' Institute of Oncology
Leeds, United Kingdom
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Centre Hospitalier Universitaire Sart Tilman Oncologie m dicale
Liège, Belgium
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UFKT - Universit ts-Frauenklinik T bingen
Tübingen, Germany
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Somogy Megyei Kaposi M r Oktat K rh z Klinikai Onkol giai Centrum Kaposv r
Kaposvár, Hungary
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