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

NCT05135104 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2023-05-17

No results posted yet for this study

Summary

PALBO is a Non-Interventional, National Study Of Real-World Evidence In Estrogen Receptor Positive, Her2 Negative Metastatic Breast Cancer Patients Treated With Palbociclib During A 2.5 Years Follow-Up Period. The primary objective is to identify pathological and clinical features of MBC that is associated with Palbociclib's best efficacy, measured by response rate (overall response rate, duration of response and best clinical response), progression free survival and OS. Safety of Palbociclib will also be evaluated.

Conditions

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.

Sponsors & Collaborators

  • MDX Research

    collaborator NETWORK

  • Asociatia Oncohelp - Centrul de Oncologie Oncohelp

    lead OTHER

Principal Investigators

  • Cristina Marinela Oprean, MD · ASOCIATIA ONCOHELP - CENTRUL DE ONCOLOGIE ONCOHELP, DEPARTMENT OF MEDICAL ONCOLOGY

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-03-25
Completion
2024-05-25
FDA Drug
Yes

Countries

  • Romania

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135104 on ClinicalTrials.gov