Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
NCT ID: NCT04874025
Last Updated: 2022-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
815 participants
OBSERVATIONAL
2021-07-31
2022-06-08
Brief Summary
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The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.
These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.
In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Ibrance
Observational study of Ibrance 75 mg, 100 mg and 125 mg.
Eligibility Criteria
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Inclusion Criteria
* 2\. Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
* 3\. HR+/HER2-
1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
* 4\. Female or male patients \> 18 years
* 5\. Have received at least one dose of palbociclib
* 6\. At least 2 document clinical visits
* 7\. Treatment with palbociclib should have started from November 2017 to November 2019
* 8\. Data from the clinical records should be available.
* 9\. Patients must be able to understand and sign informed consent if alive.
Exclusion Criteria
* 2\. Treatment with palbociclib in clinical trial or compassionate use programs
* 3\. HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
* 4\. HR negative tumors in the most recent biopsy
18 Years
ALL
No
Sponsors
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Hospital San Carlos, Madrid
OTHER
Responsible Party
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Fernando Moreno Antón
Principal Investigator
Locations
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Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Hospital Univesitario Virgen del Rocío
Seville, Andalusia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Aragon, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Hospital Son Espases
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario de Basurto
Bilbao, Basque Country, Spain
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de Guadalajara
Guadalajara, Castilla Y La Mancha, Spain
Hospital Virgen de la Salud
Toledo, Castilla Y La Mancha, Spain
Hospital Universitario de Burgos
Burgos, Castille and León, Spain
Hospital Universitario de León
León, Castille and León, Spain
Hospital del Mar
Barcelona, Catalonia, Spain
Hospital Universitario Vall d´Hebrón
Barcelona, Catalonia, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
ICO Hospitalet
L'Hospitalet de Llobregat, Catalonia, Spain
Arnau Vilanova Lleida
Lleida, Catalonia, Spain
Hospital Universitario de Cáceres
Cáceres, Extremadura, Spain
Hospital Universitario de La Coruña
A Coruña, Galicia, Spain
Hospital Universitario de Ferrol
Ferrol, Galicia, Spain
Hospital Cínico Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital General Universitario de Elche
Elche, Valencia, Spain
Hospital Universitario de la Princesa
Madrid, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Arnau Vilanova Valencia
Valencia, , Spain
Countries
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References
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Martinez-Janez N, Ezquerra MB, Manso Sanchez LM, Carrasco FH, Torres AA, Morales S, Ortega PT, Gil VLO, Sampedro T, Conejero RA, Calvo-Martinez L, Galve-Calvo E, Lopez R, de la Pena FA, Lopez-Tarruella S, de Araguiz BAHF, Ruiz LB, Cardenas TM, Chacon JI, Anton FM. First-line therapy with palbociclib in patients with advanced HR+/HER2- breast cancer: The real-life study PALBOSPAIN. Breast Cancer Res Treat. 2024 Jul;206(2):317-328. doi: 10.1007/s10549-024-07287-w. Epub 2024 Apr 1.
Other Identifiers
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PALBOSPAIN
Identifier Type: -
Identifier Source: org_study_id
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