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Clinical Trial NCT07493291 (PALLAS-IRAQ) for Brest Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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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 (PALLAS-IRAQ) 100

Active, not recruiting
Clinical Trial NCT07493291 (PALLAS-IRAQ) is an observational study for Brest Cancer that is active, not recruiting. It started on September 7, 2025 with plans to enroll 100 participants. Led by Al-Mustansiriyah University, it is expected to complete by April 20, 2026. The latest data from ClinicalTrials.gov was last updated on March 25, 2026.
Brief 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 ...Show More
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

Conditions
Brest Cancer
Publications
Scientific articles and research papers published about this clinical trial:
  • 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.
Other Study IDs
  • PALLAS-IRAQ
  • 110
  • 2025053 (Registry Identifier) (MOH, IRAQ, ALANBAR DIRECTORATE OF HEALTH)
  • 97 (Other Identifier) (UNIVERSITY OF MUSTANSIRIYAH, COLLAGE OF PHARMCY)
NCT ID Number
NCT07493291
Start Date (Actual)
2025-09-07
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-04-20
Enrollment (Estimated)
100
Study Type
Observational
Status
Active, not recruiting
Keywords
Comparative study,Drug effectiveness,Brand-name drugs,Stage IV breast cancer,Drug safety
Arms / Interventions
Participant Group/ArmIntervention/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)
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)
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  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.

  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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Al-Mustansiriyah University logoAl-Mustansiriyah University
Al-Anbar Health Organization logoAl-Anbar Health Organization
Study Responsible Party
Abdullah H Ali‬, Principal Investigator, CLINICAL PHARMICIST, Al-Mustansiriyah University
No contact data.
1 Study Locations in 1 Countries

Anbar/Ramadi

Anbar cancer center, Alanbar, Anbar/Ramadi, 10003, Iraq