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NCT Number: NCT06338644

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

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

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Key information

Conditions

Hormone-receptor-positive Breast Cancer Breast Diseases Breast Neoplasms Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Metastatic Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

  • Prior exposure to fulvestrant or everolimus.
  • Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
  • Patients refusing to sign the written informed consent.

Treatment and study plan

Palbociclib

Drug

3 weeks on, 1 week off

Primary outcomes

  1. 1-year Progression free survival (PFS)

    Time frame: 1 year

    the time from enrollment until first evidence of disease progression or death

Secondary outcomes

  1. Neutropenia

    Time frame: 1 year

    Grade 3 or 4 neutropenia

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Acronym: Palbociclib

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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