PALMIRA

OFFICIAL TITLE: PALBOCICLIB RECHALLENGE IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER – PALMIRA.

CLINICAL TRIAL DETAILS

INTERNATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE II CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CONTINUATION OF PALBOCICLIB IN COMBINATION WITH SECOND-LINE ENDOCRINE THERAPY IN HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER PATIENTS WHO HAVE ACHIEVED CLINICAL BENEFIT DURING FIRST-LINE PALBOCICLIB-BASED TREATMENT.

THE PRIMARY GOAL IS TO COMPARE THE EFFICACY, DEFINED AS PROGRESSION-FREE SURVIVAL (PFS), OF CONTINUATION OF PALBOCICLIB TREATMENT COMBINED WITH SECOND-LINE ENDOCRINE THERAPY (FULVESTRANT OR LETROZOLE) VERSUS ENDOCRINE THERAPY ALONE IN PRE- AND POST-MENOPAUSAL WOMEN WITH HR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER (ABC).

IN ADDITION, TO EXPLORE POTENTIAL MOLECULAR MARKERS OF SENSITIVITY AND/OR RESISTANCE FOR THE COMBINATION AND ENDOCRINE THERAPY ALONE.

 

PALMIRA AT CLINICALTRIALS.GOV

TUMOR TYPE

PHASE

N

SITES

COUNTRY

STATUS

HER2+ ABC

II

198

54

Spain, France, Italy, UK, Germany, Slovenia

Recruiting

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PALMIRA SITES

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SPAIN

Hospital Arnau de Vilanova

SPAIN

Instituto Valenciano de Oncología (IVO)

SPAIN

Hospital Universitari i Politècnic La Fe

SPAIN

Consorci Hospital General Universitari de València

SPAIN

Hospital Provincial de Castellón

SPAIN

 Hospital Universitari Vall D'Hebron

SPAIN

Hospital del Mar

SPAIN

Instituto Oncológico Baselga - Hospital Quiron Salud Barcelona

SPAIN

Institut Català d' Oncologia L'Hospitalet (ICO)

SPAIN

Institut Català d' Oncologia Badalona (ICO)

SPAIN

Institut Català d' Oncologia Girona (ICO)

SPAIN

Consorci Hospitalari de Terrassa

SPAIN

Hospital Universitari Sant Joan de Reus

SPAIN

Hospital Universitario Arnau de Vilanova de Lleida

SPAIN

Hospital Universitari Son Espases

SPAIN

Hospital Clínico Universitario Lozano Blesa

SPAIN

Hospital Universitario Miguel Servet

SPAIN

Hospital Clínico San Carlos

SPAIN

Hospital Universitario La Paz

SPAIN

Hospital Universtitario Sanchinarro

SPAIN

Hospital Universitario de Basurto

SPAIN

Centro Oncológico de Galicia

SPAIN

Hospital Álvaro Cunqueiro

SPAIN

Hospital Universitario Virgen del Rocío

SPAIN

Hospital Universitario Virgen de la Macarena

SPAIN

Hospital Regional Universitario de Málaga (Hospital Carlos Haya)

SPAIN

Hospital San Pedro de Alcántara

FRANCE

Hopital Europeen Georges Pompidou

FRANCE

Hôpital Tenon AP-HP

FRANCE

Centre Paul Strauss

FRANCE

Hôpital Jean Minjoz

FRANCE

Centre Georges François Leclerc

FRANCE

Hospital Center Departmental Vendée

ITALY

Instituto Europeo di Oncologia

ITALY

Ospedale San Raffaello

ITALY

Ospedale Civili Brescia

ITALY

Policlinico Universitario Campus Bio-medico, Roma

UK

Barts Cancer Institute

UK

Beatson West of Scotland Cancer Center

UK

Maidstone- Kent Oncology Department

UK

Abertawe Bro Morgannwg University Local Health Board, Singleton Hospital

UK

Royal Cornwall Hospital NHS Trust

UK

Darent Valley Hospital by Dartford and Gravesham NHS Trust

GERMANY

Technical University Munich

GERMANY

Klinikum Mutterhaus der Borromäerinnen Trier

GERMANY

Kliniken Essen Mitte

GERMANY

UKM Brustzentrum

GERMANY

University Hospital Dresden-GYN

GERMANY

Klinikum Ernst von Bergmann

GERMANY

Universitätsklinikum Essen Frauenklinik

GERMANY

AGAPLESION Markus Krankenhaus

SLOVENIA

Onkološki Inštitut Ljubljana

SLOVENIA

Univerzitetni klinicni center Maribor Oddelek za onkologijo