רדאר קליני AI | ||
|---|---|---|
הניסוי הקליני NCT07493291 (PALLAS-IRAQ) עבור Brest Cancer הוא פעיל, לא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
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
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
- 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.
- PALLAS-IRAQ
- 110
- 2025053 (מזהה רישום) (MOH, IRAQ, ALANBAR DIRECTORATE OF HEALTH)
- 97 (מזהה אחר) (UNIVERSITY OF MUSTANSIRIYAH, COLLAGE OF PHARMCY)
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
• 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. |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
- 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.
- 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 UniversityAl-Anbar Health OrganizationAnbar/Ramadi