Trials / Not Yet Recruiting
Not Yet RecruitingNCT06338644
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Helwan University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed 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
Conditions
- Hormone-receptor-positive Breast Cancer
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Palbociclib | 3 weeks on, 1 week off |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2025-09-01
- Completion
- 2026-09-01
- First posted
- 2024-03-29
- Last updated
- 2024-03-29
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06338644. Inclusion in this directory is not an endorsement.