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Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
Sponsor: Al-Mustansiriyah University
Summary
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
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-09-07
Completion Date
2026-04-20
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Palbociclib (Brand vs Generic) compartive
Participants will receive palbociclib, either the brand-name formulation (Ibrance) or a locally manufactured generic equivalent, in combination with standard endocrine therapy. The study compares the effectiveness and safety of the brand versus generic formulations in patients with stage IV hormone receptor-positive, HER2-negative breast cancer.
Locations (1)
Anbar cancer center
Ramadi, Al-Anbar Governorate, Iraq