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NCT06338644 Clinical Trial

Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Metastatic Breast Cancer Clinical Trial

— Palbociclib  

Official title:
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06338644
Other study ID # HelwanUY
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date September 1, 2026

Study information
Verified date March 2024
Source Helwan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cyclin-dependent kinase (CDK) 4/6 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive (HR+) and HER2-negative (HER2-) BC. Palbociclib, ribociclib and abemaciclib have all been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency among other regulatory bodies

Description:

Several factors are thought to influence the variability of treatment efficacy and toxicity, including organ function, comedications, hormonal status, body weight, age, comorbidities, etc. Among them, single nucleotide polymorphisms (SNPs) as rs1128503, rs2032583 are attracting huge interest to address the interindividual variability in drug response, whether in terms of efficacy or safety

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date September 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - 1. Adult patients (=18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples. 4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting. Exclusion Criteria: 1. Prior exposure to fulvestrant or everolimus. 2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications. 3. Patients refusing to sign the written informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Palbociclib
3 weeks on, 1 week off

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Helwan University

Outcome
Type Measure Description Time frame Safety issue
Primary 1-year Progression free survival (PFS) the time from enrollment until first evidence of disease progression or death 1 year
Secondary Neutropenia Grade 3 or 4 neutropenia 1 year
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