Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period

UnknownOBSERVATIONAL
Enrollment

650

Participants

Timeline

Start Date

December 15, 2021

Primary Completion Date

March 25, 2024

Study Completion Date

May 25, 2024

Conditions
Metastatic Breast Cancer
Interventions
DRUG

Palbociclib

"Palbociclib, an orally active pyridopyrimidine, is a potent and highly selective reversible inhibitor of CDK 4 and CDK6. The compound prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 into the S phase. Specifically, Palbociclib inhibits CDK4/6-catalyzed phosphorylation of the retinoblastoma protein (Rb), which is required for cell division.~Palbociclib has selectivity for CDK4/6, with little or no activity against a large panel of 274 other protein kinases including other CDKs and a wide variety of tyrosine and serine/threonine kinases.~Therapeutic indications:~Palbociclib is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or MBC:~* in combination with an aromatase inhibitor;~* in combination with fulvestrant in women who have received prior endocrine therapy."

Trial Locations (7)

200746

RECRUITING

"Centrul de Oncologie Sf. Nectarie", Craiova

300239

RECRUITING

Asociatia Oncohelp - Centrul de Oncologie Oncohelp, Timișoara

400015

RECRUITING

"Institutul Oncologic Prof. Dr I. Chiricuta", Cluj-Napoca

400349

RECRUITING

Spitalul Clinic Județean de Urgență Cluj-Napoca, Cluj-Napoca

410469

RECRUITING

Spitalul Clinic Județean de Urgență Oradea, Oradea

700483

RECRUITING

Institutul Regional de Oncologie, Iași

011171

RECRUITING

Spitalul Clinic de Obstetrică Și Ginecologie Filantropia, Bucharest

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MDX Research

NETWORK

lead

Asociatia Oncohelp - Centrul de Oncologie Oncohelp

OTHER

NCT05135104 - Study Of Real-World Evidence In Patients Treated With Palbociclib During a 2.5 Years Follow-Up Period | Biotech Hunter | Biotech Hunter