Clinical trial · Observational
Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
NCT06338644CI-TRIAL-00075538PalbociclibunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone-receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Primary resistant to endocrine therapy
- description
- Primary endocrine resistance is defined as a relapse within 2 years of adjuvant endocrine treatment or disease progression during the first 6 months of first-line endocrine therapy for advanced or MBC
- interventionNames
- Drug: Palbociclib
- label
- Secondary resistant to endocrine therapy
- description
- Secondary resistance is defined in early BC as a relapse that occurs after at least 2 years of endocrine therapy and during or within the first year of completing adjuvant endocrine therapy. In advanced BC or MBC, secondary resistance is defined as disease progression after more than 6 months of endocrine therapy
- interventionNames
- Drug: Palbociclib
Primary outcomes (1)
- measure
- 1-year Progression free survival (PFS)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMohamed 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