NCT07493291

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The main problem, though, is that there is no local study performed that evaluates the effectiveness, safety, and tolerability of palbociclib in Iraqi patients. Although conducted worldwide, the clinical benefit established with palbociclib may not apply to the outcomes in Iraq, due to the difference in patients, the health care system, and continuity of treatment, which do not resemble those present in countries of high income. Another equally urgent problem is the absence of comparative studies performed on the branded palbociclib (Ibrance®) and the versions that are now entering the Iraqi market. The high cost of branded forms of palbociclib and the out-of-pocket payment in the bulk of them make it necessary for patients to resort to the generic forms, in view of the absence of comparative data showing clinical equivalence. The oncologists, at the same time, lack data that show whether substitution leads to any loss of efficacy or safety, and the information is lacking to determine the consequences of procurement and reimbursement policies. Thus, the problem addressed in this thesis is two-fold in nature: (1) the absence of real-world data on the outcome of palbociclib therapy in Iraqi breast cancer patients and the absence of comparative studies on branded versus generic evaluations in Iraq. In the absence of local data, treatment will have to be based on result extrapolation from foreign studies instead of local data, which may lead to undesirable results in the way of results and efficiency of administration of limited health care resources.

Conditions

• Brest Cancer
• CDK4/6 Inhibitor

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-09-07
• Primary completion: 2026-03-01
• Completion: 2026-04-20
• First posted: 2026-03-25
• Last updated: 2026-03-30

Locations

1 site across 1 country: Iraq

Regulatory

• FDA-regulated drug study