Clinical trial · Observational
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Hormone Receptor-positive / Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer Patients: A Comparative Study
NCT07493291CI-TRIAL-00106808PALLAS-IRAQactive not recruitingClinicalTrials.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)
This study aims to evaluate the efficacy and safety of branded palbociclib (Ibrance®) compared to available local generic formulations (Palbociclib-IPI) in Iraqi patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer (HR+ HER2- BC). This research aims to provide evidence
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brest Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| CDK4/6 Inhibitor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib (Brand vs Generic) compartive | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- • Prospective arm for patients currently receiving generic Palbociclib
- description
- • Group B (n=30-50): Currently receiving Palbociclib-IPI (prospective follow-up for at least 3 months)
- interventionNames
- Drug: Palbociclib (Brand vs Generic) compartive
- label
- Retrospective arm for patients treated with branded Palbociclib (Ibrance®)
- description
- Group A (n=30-50): Received Ibrance® (retrospective data from oncology centers' archives)
Primary outcomes (1)
- measure
- The primary efficacy endpoint is defined as progression free survival (PFS)
- timeFrame
- two years
- description
- which is referred to as the time from initiation of treatment which is recorded to the time that documented disease progression occurs or death post treatment for any cause.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females ≥ 18 years. 2. Histological or cytological confirmation of HR+/HER2- advanced or metastatic breast cancer according to international criteria for pathology. 3\. Patients evaluated prior to treatment with letrozole or fulvestrant having had at least 1 cycle of palbociclib (retrospectively, Ibrance® or prospectively, Palbociclib-IPI) for HR+/HER2- advanced or metastatic breast cancer. 4\. Availability of a complete history and physical examination, laboratory tests, and imaging studies of the patients, including baseline and follow-up tests and examinations. 5\. For the prospective group, the patients had to be willing to give informed consent for evaluation of quality of life and for evaluation of medical data. Exclusion Criteria: 1. Male breast cancer patients, due to a different biology and small population proportion in Iraq. 2\. Patients with HER2-positive or triple-negative breast cancer, due to different algorithms for treatment and prognosis. 3\. Patients previously receiving CDK4/6 inhibition apart from palbociclib (ribociclib or abemaciclib) so as to not have biased results. 4\. Patients without complete medical history or follow-up sufficient to evaluate reliable outcomes. 5\. Patients with other cancers or severe comorbidities which had a direct impact on survival results independent of breast cancer per criteria done in other real-world observational cohorts \-
References
Publications (1)
- RESULTBenitez Fuentes JD, Morgan E, de Luna Aguilar A, Mafra A, Shah R, Giusti F, Vignat J, Znaor A, Musetti C, Yip CH, Van Eycken L, Jedy-Agba E, Pineros M, Soerjomataram I. Global Stage Distribution of Breast Cancer at Diagnosis: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jan 1;10(1):71-78. doi: 10.1001/jamaoncol.2023.4837. PMID 37943547