Spots Global Cancer Trial Database for Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1
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Trial Identification
Brief Title: Neoadjuvant Therapy in TRIPle Negative Breast Cancer With antiPDL1
Official Title: Neo-Adjuvant Study With the PDL1-directed Antibody in Triple Negative Locally Advanced Breast Cancer Undergoing Treatment With Nab-paclitaxel and Carboplatin
Study ID: NCT02620280
Conditions
Study Description
Brief Summary: This study that aims to evaluate the addition of MPDL3280A (atezolizumab) to carboplatin and nab-paclitaxel in patients with early high-risk and locally advanced triple negative breast cancer. compared to the control arm of carboplatin and abraxane. Half of participants will receive MPDL3280A in combination with carboplatin and abraxane, while the other half will receive only carboplatin and abraxane.
Detailed Description: Emerging evidence shows that many breast cancers with triple negative and basal like features have infiltration by mononuclear cells and lymphocytes. Irrespective of the entity of tumor infiltration by mononuclear cells, expression of immune regulatory checkpoints such as PD-1 and its ligand B7-H1 (or PD-L1) negatively affect the results of treatments. These data suggest that a subset of patients have an ongoing immune response within the tumor micro-environment, and that PD-L1 expression is an adaptive method of tumor resistance to tumor infiltrating lymphocytes, which in turn are needed for response to chemotherapy. Overall, the data suggests a role for immune regulation of response to chemotherapy, and support the concept that blockade of immune check-points may favor the achievement of durable response by immune mechanisms themselves, and in combination with classical chemotherapy. MPDL3280A (atezolizumab) is a human monoclonal antibody containing an engineered Fc-domain to optimize efficacy and safety that targets PD-L1 and blocks binding of its receptors, including PD-1 and B7.1. Based on these considerations, we plan to conduct a study of the combination of abraxane and carboplatin with or without PDL1-directed antibody in women with locally advanced breast cancer suitable for neoadjuvant therapy with the aim to improve event-free survival
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Brustgesundheitzentrum Tirol, Univ. Frauenklinik Innsbruck, Innsbruck, , Austria
Universitätsklinik für Innere Medizin III, mit Hämatologie, internistischer Onkologie, Hämostaseologie, Infektiologie, Rheumatologie und Onkologisches Zentrum, Salzburg, , Austria
Klinikum Augsburg International Patient Service, Augsburg, , Germany
Frauenarzt-Zentrum-Zehlendorf, Berlin, , Germany
Augusta-Kranken-Anstalt gGmbH Klinik für Hämatologie, Onkologie & Palliativmedizin, Bochum, , Germany
Bethanien-Krankenhaus Onkologisches Zentrum, Frankfurt, , Germany
Markus Krankenhaus Klinik für Gynäkologie und Geburtshilfe, Frankfurt, , Germany
Gynäkologisch-Onkologische Praxis, Hannover, , Germany
NCT Nationales Centrum für Tumorerkrankungen, Heidelberg, , Germany
Uniklinik Köln Klinik und Poliklinic für Frauenheilkunde und Geburtshilfe Brestzentrum, Köln, , Germany
Brustzentrum St. Elisabeth-Krankenhaus, Köln, , Germany
Interdisciplinary Oncology Center (IOZ), Munchen, , Germany
Cork University Hospital, Cork, , Ireland
Beaumont Hospital, Dublin, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
St. James's Hospital, Dublin, , Ireland
University Hospital Waterford, Waterford, , Ireland
Policlinico S. Orsola Malpoghi, Bologna, , Italy
Istituto per la Ricerca sul Cancro, Candiolo, , Italy
IST San Martino, Genova, , Italy
Istituto Toscano Tumori Ospedale Misericordia, Grosseto, , Italy
Ospedale San Raffaele, Milano, , Italy
Fondazione IRCCS Istituto nazionale dei Tumori, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale Luigi Sacco, Milano, , Italy
Arcispedale Santa Maria Nuova - A.O. Reggio Emilia, Reggio Emilia, , Italy
Ospedale Santa Maria della Misericordia, Udine, , Italy
Russian Cancer Research Center named after N.N.Blokhin, Moscow, , Russian Federation
Petrov Research Institute of Oncology, Department of Breast Cancer, Saint Petersburg, , Russian Federation
Road clinical hospital of OJSC "Russian Railways, Saint Petersburg, , Russian Federation
Hospital Duran i Reynal Institut Català d'Oncologia, Hospitalet de Llobregat, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de octubre, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Centro Integral Oncologico Clara Campal (CIOCC), Madrid, , Spain
Hospital Clinico Universitario de Valencia Servicio de Onco-Hematologia, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
C. Christian Hospital Taiwan, Changhua City, , Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
China Medical University Hospital No.2, Taichung City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Veteran General Hospital Taipei, Taipei, , Taiwan
Contact Details
Name: Luca Gianni, MD
Affiliation: Ospedale San Raffaele
Role: STUDY_CHAIR
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