NCT07493291Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 7 Sept 2025
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Al-Mustansiriyah University
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07493291
What you commit to
- Study type: Observational
- Planned participants: 100
- From 7 Sept 2025 to the primary completion date, 1 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3\. Patients previously receiving CDK4/6 inhibition apart from palbociclib (ribociclib or abemaciclib) so as to not have biased results.
Other illness
- 2\. Patients with HER2-positive or triple-negative breast cancer, due to different algorithms for treatment and prognosis.
- 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
Other
- 4\. Patients without complete medical history or follow-up sufficient to evaluate reliable outcomes.
- \-
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anbar cancer center Coordinator of this site? Confirm its status | Ramadi | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.