Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palbociclib.
- Who it may be relevant to
- Registry conditions: Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Metastatic Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Palbociclib
3 weeks on, 1 week off
Primary outcome measures
- 1-year Progression free survival (PFS) [Time frame: 1 year]
Secondary outcome measures (1)
- Neutropenia [Time frame: 1 year]
Eligibility criteria
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Mohamed Ebid AI, Fahim Genina YM, Shawky Haffez HR, Ahmed Hakam SH, Hassan Kassem LM, Mohamed AbdelMotaleb SM. Palbociclib in endocrine-resistant metastatic breast cancer: real-world outcomes. Expert Rev Anticancer Ther. 2026 Feb;26(2):263-272. doi: 10.1080/14737140.2025.2560941. Epub 2025 Sep 21. PMID 40957562
Identifiers
NCT: NCT06338644 · HelwanUY