Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients

N/AActive Not RecruitingNCT07493291

Al-Mustansiriyah University100 enrolled

Overview

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

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

100

Conditions

Brest Cancer CDK4/6 Inhibitor

Interventions

Palbociclib (Brand vs Generic) compartiveDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

Anbar cancer center

Ramadi, Al-Anbar Governorate, Iraq

Outcomes

Primary Outcomes

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.

Time frame: two years

Secondary Outcomes

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

Time frame: two years

Data from ClinicalTrials.gov

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