Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT04874025
- Lead Sponsor
- Hospital San Carlos, Madrid
- Brief Summary
Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 815
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- Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
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- Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
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HR+/HER2-
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HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
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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
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- Female or male patients > 18 years
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- Have received at least one dose of palbociclib
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- At least 2 document clinical visits
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- Treatment with palbociclib should have started from November 2017 to November 2019
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- Data from the clinical records should be available.
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- Patients must be able to understand and sign informed consent if alive.
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- Previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. Previous anticancer treatment for early breast cancer are allowed.
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- Treatment with palbociclib in clinical trial or compassionate use programs
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- HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
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- HR negative tumors in the most recent biopsy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Real-world progression free survival (rwPFS) From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months
- Secondary Outcome Measures
Name Time Method Overall Survival Time Frame: From date of index treatment until date of death from any accuse or date of end of study, whichever came first, assessed up to 52 months Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.
Real-world tumor response (rwTR) From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment
Time to first use of chemotherapy From date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months
Time to next line of therapy From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months
Trial Locations
- Locations (36)
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Andalucía, Spain
Hospital Univesitario Virgen del Rocío
🇪🇸Sevilla, Andalucía, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Andalucía, Spain
Hospital del Mar
🇪🇸Barcelona, Cataluña, Spain
Clínica Universitaria de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Andalucía, Spain
Hospital Universitario Vall d´Hebrón
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario de La Coruña
🇪🇸A Coruña, Galicia, Spain
Hospital Universitario de Basurto
🇪🇸Bilbao, Pais Vasco, Spain
Hospital Cínico Universitario de Santiago de Compostela
🇪🇸Santiago De Compostela, Galicia, Spain
Hospital Son Espases
🇪🇸Palma De Mallorca, Islas Baleares, Spain
Hospital Universitario de Ferrol
🇪🇸Ferrol, Galicia, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Clínico Universitario Lozano Blesa
🇪🇸Zaragoza, Aragón, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Aragón, Spain
Hospital Universitario de Cabueñes
🇪🇸Gijón, Asturias, Spain
Hospital Virgen de la Salud
🇪🇸Toledo, Castilla Y La Mancha, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Castilla Y León, Spain
Arnau Vilanova Lleida
🇪🇸Lleida, Cataluña, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
ICO Hospitalet
🇪🇸L'Hospitalet De Llobregat, Cataluña, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Comunidad Valenciana, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario de Guadalajara
🇪🇸Guadalajara, Castilla Y La Mancha, Spain
Hospital Universitario de León
🇪🇸León, Castilla Y León, Spain
Hospital Universitario Donostia
🇪🇸Donostia, Pais Vasco, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario de Cáceres
🇪🇸Cáceres, Extremadura, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Arnau Vilanova Valencia
🇪🇸Valencia, Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain