Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
NCT ID: NCT02491983
Last Updated: 2024-12-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
486 participants
INTERVENTIONAL
2015-08-31
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Combination of Palbociclib and Letrozole
Palbociclib
Letrozole
Arm B
Combination of Palbociclib and Fulvestrant
Palbociclib
Fulvestrant
Interventions
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Palbociclib
Fulvestrant
Letrozole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Confirmed diagnosis of HR+/HER2- breast cancer
3. Post-menopausal status
4. No prior chemotherapy line in the metastatic setting
5. Measurable disease defined by RECIST version 1.1, or non-measurable disease
6. Eastern Cooperative Oncology Group (ECOG) PS 0-1
7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
8. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1
Exclusion Criteria
2. HER2 positive disease based on local laboratory results
3. Locally advanced breast cancer candidate for a radical treatment
4. Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
5. Patients with rapidly progressive visceral disease or visceral crisis.
6. Major surgery within 4 weeks of start of study drug
7. Patients with an active, bleeding diathesis
8. Serious concomitant systemic disorder incompatible with the study
9. Are unable to swallow tablets
10. Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
11. Known active uncontrolled or symptomatic CNS metastases
12. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
13. QTc \> 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
14. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug
18 Years
FEMALE
No
Sponsors
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MedSIR
OTHER
Responsible Party
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Principal Investigators
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Antonio Llombart, MD
Role: PRINCIPAL_INVESTIGATOR
MedSIR
Locations
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MedSIR investigative site
Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Paris, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Dessau, , Germany
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Heidelberg, , Germany
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Brindisi, , Italy
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Cagliari, , Italy
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Cremona, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Monza, , Italy
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Piacenza, , Italy
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Torino, , Italy
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Bilbao, , Spain
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Castelló, , Spain
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Cáceres, , Spain
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Córdoba, , Spain
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Girona, , Spain
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Huelva, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Pamplona, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Tarragona, , Spain
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Valencia, , Spain
MedSIR investigative site B
Zaragoza, , Spain
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Zaragoza, , Spain
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Bath, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Nottingham, , United Kingdom
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Romford, , United Kingdom
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Swansea, , United Kingdom
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Truro, , United Kingdom
Countries
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References
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Di Cosimo S, Perez-Garcia JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-De Duenas E, Caranana V, Amillano K, Mina L, Malfettone A, Cortes J, Llombart-Cussac A. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Oncologist. 2023 Jan 18;28(1):23-32. doi: 10.1093/oncolo/oyac205.
Llombart-Cussac A, Perez-Garcia JM, Bellet M, Dalenc F, Gil-Gil M, Ruiz-Borrego M, Gavila J, Sampayo-Cordero M, Aguirre E, Schmid P, Marme F, Di Cosimo S, Gligorov J, Schneeweiss A, Albanell J, Zamora P, Wheatley D, Martinez-de Duenas E, Amillano K, Malfettone A, Cortes J; PARSIFAL Steering Committee and Trial Investigators. Fulvestrant-Palbociclib vs Letrozole-Palbociclib as Initial Therapy for Endocrine-Sensitive, Hormone Receptor-Positive, ERBB2-Negative Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2021 Dec 1;7(12):1791-1799. doi: 10.1001/jamaoncol.2021.4301.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2014-004698-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MedOPP067
Identifier Type: -
Identifier Source: org_study_id