Spots Global Cancer Trial Database for PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
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Trial Identification
Brief Title: PALbociclib Rechallenge in horMone Receptor-posItive/HER2- Negative Advanced Breast Cancer (PALMIRA)
Official Title: International,Multicenter,Randomized,Open-label, Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib+2nd Line Endocrine Therapy in HR+/HER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib.
Study ID: NCT03809988
Study Description
Brief Summary: Hormone Receptor (HR)-positive/Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced breast cancer (ABC)
Detailed Description: Pre- and post-menopausal women age ≥ 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment. Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible. Patients are not eligible if they are candidates for a local treatment with a curative intention. Evidence of either measurable and biopsiable metastatic disease (as for Response Evaluation Criteria In Solid Tumors (RECIST v.1.1)) or non-measurable disease with bone lesion is required. Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone (LHRH) analogues.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hôpital Jean Minjoz, Besançon, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Centre Georges François Leclerc, Dijon, , France
CHD Vendee, La Roche-sur-Yon, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hôpital Tenon AP-HP, Paris, , France
Centre Paul Strauss, Strasbourg, , France
University Hospital Dresden-GYN, Dresden, , Germany
Kliniken Essen Mitte, Essen, , Germany
Universitätsklinikum Essen Frauenklinik, Essen, , Germany
AGAPLESION Markus Krankenhaus, Frankfurt, , Germany
Technical University Munich, Munich, , Germany
UKM Brustzentrum, Münster, , Germany
Klinikum Ernst von Bergmann, Potsdam, , Germany
Klinikum Mutterhaus der Borromäerinnen Trier, Trier, , Germany
Ospedale Civili Brescia, Brescia, , Italy
Instituto Europeo di Oncologia, Milano, , Italy
Oncologia Medica Ospedale di Prato, Prato, , Italy
Policlinico Universitario Campus Bio-medico, Roma, , Italy
Onkološki Inštitut Ljubljana, Ljubljana, , Slovenia
Univerzitetni klinicni center Maribor Oddelek za onkologijo, Maribor, , Slovenia
ICO Badalona, Badalona, Barcelona, Spain
Hospital Provincial de Castellón, Castello, Castelló, Spain
Consorci Sanitari de Terrassa, Terrassa, Terrasa, Spain
Centro Oncológico de Galicia, A Coruña, , Spain
Institut Català d'Oncologia Bellvitge, Barcelona, , Spain
H. Vall Hebrón, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Institut Català d'Oncologia, Girona, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Sanchinarro, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
Hospital Sant Joan, Reus, , Spain
Hospital Universitario Virgen de la Macarena, Sevilla, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Instituto Valenciano de Oncología IVO, Valencia, , Spain
Hospital General Universitari de Valencia, Valencia, , Spain
Hospital Arnau de Vilanova de Valencia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Hospital Álvaro Cunqueiro, Vigo, , Spain
Hospital Lozano Blesa, Zaragoza, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Darent Valley Hospital by Dartford and Gravesham NHS Trust, Dartford, , United Kingdom
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
Barts Cancer Institute, London, , United Kingdom
Kent Oncology Department, Maidstone, , United Kingdom
Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital, Swansea, , United Kingdom
Royal Cornwall Hospital NHS Trust, Truro, , United Kingdom
Contact Details
Name: José Perez
Affiliation: MedSIR
Role: PRINCIPAL_INVESTIGATOR
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