Spots Global Cancer Trial Database for Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
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Trial Identification
Brief Title: Schedules of Nab-Paclitaxel in Metastatic Breast Cancer
Official Title: A Randomized Phase II Study Evaluating Different Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP Trial)
Study ID: NCT01746225
Conditions
Interventions
Study Description
Brief Summary: Longer first line chemotherapy duration has recently been associated with a modest, but significant improvement in overall survival and a clinically meaningful and statistically significant improvement in progression-free survival, in metastatic breast cancer patients. Prolonging chemotherapy until disease progression, however, must be weighed against the detrimental effects of continuous chemotherapy delivery. The SNAP trial seeks to improve the tolerability of prolonged chemotherapy administration strategy by studying alternative treatment schedules, while preserving and possibly improving treatment efficacy in this disease setting. The availability of a new nanoparticle albumin-bound taxane, nab-Paclitaxel (Abraxane®), represents an opportunity to test this hypothesis. Nab-Paclitaxel has been developed in an attempt to reduce the toxicity associated with standard taxane administration (caused by the use of chemical solvents) while increasing antitumor efficacy. The SNAP randomized phase II trial evaluates three schedules of nab-Paclitaxel as prolonged chemotherapy administration strategy. Each of three arms will be compared to a historical reference of seven-month median progression-free survival (PFS) based on the most recent trial with docetaxel as control arm to determine whether any of the three arms are worthy of further investigation.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
CHR de la Citadelle, Oncology-Haematology Unit, Liège, , Belgium
CHU Sart Tilman, Medical Oncology, Liège, , Belgium
Centre Hospitalier Peltzer-La Tourelle, Department of Clinical Cancerology, Verviers, , Belgium
Bon Secours, Cork, , Ireland
Cork University Hospital, Cork, , Ireland
Beaumont Hospital, Dublin, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
Mater Private Hospital, Dublin, , Ireland
St James's Hospital, Dublin, , Ireland
St Vincent's University Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Mid-Western Regional Hospital, Limerick, , Ireland
Waterford Regional Hospital, Waterford, , Ireland
Azienda Ospedaliera SS Antonio e Biagio, Alessandria, , Italy
Ospedale degli Infermi, Biella, , Italy
IRCCS MultiMedica, Castellanza, , Italy
E.O. Ospedali Galliera, Genova, , Italy
Istituto Europeo di Oncologia (IEO), Milano, , Italy
Uo Medicina Ocologica Ospedale Di Carpri e Mirandola, Azienda USL di Modena, Modena, , Italy
Fondazione Salvatore Maugeri, Pavia, , Italy
U.O. Oncologia, AUSL Rimini, Rimini, , Italy
Universita degli Studi di Roma La Sapienza, Roma, , Italy
Azienda Osp. Universitaria di Udine, Udine, , Italy
Ospedale di Circolo e Fondatione Macchi, Varese, , Italy
Institute of Oncology, Ljubljana, , Slovenia
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Consorcop Hospitalario Provincial De Castellon, Castelló, , Spain
Hospital Universitari Arnau De Vilanova De Lleida, Lleida, , Spain
Hospital Universitari Sant Joan De Reus, Tarragona, , Spain
Hospital Universitario Lozano Blesa De Zaragoza, Zaragoza, , Spain
Kantonsspital Aarau, Aarau, , Switzerland
Universitätsspital Basel, Basel, , Switzerland
Instituto Oncologico della Svizzera Italiana, Bellinzona, , Switzerland
Universitätsspital/ Inselspital Bern, Bern, , Switzerland
Spitalzentrum Biel, Biel, , Switzerland
Kantonsspital Graubünden, Chur, , Switzerland
Kantonsspital Baselland, Liestal, , Switzerland
Luzerner Kantonsspital, Luzern, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Onkologiezentrum Thun-Berner Oberland, Thun, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Contact Details
Name: Alessandra Gennari, MD
Affiliation: Division of Medical Oncology, E.O. Galliera, Genoa, Italy
Role: STUDY_CHAIR
Name: Guy Jerusalem, MD, PhD
Affiliation: CHU Sart Tilman and University of Liège, Liège, Belgium
Role: STUDY_CHAIR
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