Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients (PALLAS-IRAQ)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: CDK4/6 Inhibitor; Brest Cancer
• Intervention / Treatment: Drug: Palbociclib (Brand vs Generic) compartive

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Iraq
  • Al-Anbar Governorate
    • Ramadi, Al-Anbar Governorate, Iraq, 10003
      • Anbar cancer center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study involved women who are adults with hormone receptor-positive (HR+) and negative (HER2-) advanced or metastatic breast cancer patients who received systemic therapy that comprised palbociclib combined with endocrine therapy (e.g., letrozole or fulvestrant).

Description

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

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
• Prospective arm for patients currently receiving generic Palbociclib; • Group B (n=30-50): Currently receiving Palbociclib-IPI (prospective follow-up for at least 3 months)	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.
Retrospective arm for patients treated with branded Palbociclib (Ibrance®); Group A (n=30-50): Received Ibrance® (retrospective data from oncology centers' archives)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary efficacy endpoint is defined as progression free survival (PFS)	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.	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy endpoints used include overall response rate (ORR)	which has been defined as the proportion of patients achieving either complete or partial tumor response	two years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
secondary disease control rate (DCR)	which includes stable disease over a period in excess of 24 weeks. Tumor assessment was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) assessment at all times to ensure comparability not only with global trial database but in addition with other real-life experience	two years

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University
• Collaborators: Al-Anbar Health Organization
• Investigators: Study Chair: Hadeel D. Najem, Clinc pharmD, university of mustansiriyah collage of pharmacy; Principal Investigator: Nabeel M Talib, MD,Oncology, Anbar cancer center

Publications and helpful links

General Publications

• Fuentes JDB, Morgan E, de Luna Aguilar A, Mafra A, Shah R, Giusti F, et al. Global stage distribution of breast cancer at diagnosis: a systematic review and meta-analysis. JAMA oncology. 2024;10(1):71-8.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2025
• Primary Completion (Actual): March 1, 2026
• Study Completion (Estimated): April 20, 2026

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Comparative study; Palbociclib; Stage IV breast cancer; Drug effectiveness; Brand-name drug; Safety drug
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; palbociclib
• Other Study ID Numbers: 110; 97 (Other Identifier: UNIVERSITY OF MUSTANSIRIYAH, COLLAGE OF PHARMCY); 2025053 (Registry Identifier: MOH, IRAQ, ALANBAR DIRECTORATE OF HEALTH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared upon reasonable request."
• IPD Sharing Time Frame: start one year after publication
• IPD Sharing Access Criteria: "Access to de-identified individual participant data will be granted to qualified researchers upon reasonable request, subject to approval by the study investigators and the University of Mustansiriyah ethics committee."
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes