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

NCT07493291 | Active Not Recruiting FDA Drug

• 3 other identifiers: 110202505397
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Brest Cancer; CDK4/6 Inhibitor

Keywords

Comparative study; Drug effectiveness; Brand-name drug; Palbociclib; Stage IV breast cancer; Safety drug

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary efficacy endpoints used include overall response rate (ORR)

  two years

Other Outcomes (1)

• secondary disease control rate (DCR)

  two years

Study Arms (2)

• 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

Retrospective arm for patients treated with branded Palbociclib (Ibrance®)

Group A (n=30-50): Received Ibrance® (retrospective data from oncology centers' archives)

Interventions

Palbociclib (Brand vs Generic) compartive DRUG

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.

• Prospective arm for patients currently receiving generic Palbociclib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \. 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.
• \. Availability of a complete history and physical examination, laboratory tests, and imaging studies of the patients, including baseline and follow-up tests and examinations.
• \. 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.

You may not qualify if:

• \. Patients with HER2-positive or triple-negative breast cancer, due to different algorithms for treatment and prognosis.
• \. Patients previously receiving CDK4/6 inhibition apart from palbociclib (ribociclib or abemaciclib) so as to not have biased results.
• \. Patients without complete medical history or follow-up sufficient to evaluate reliable outcomes.
• \. 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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead
• Al-Anbar Health Organization: collaborator

Study Sites (1)

Anbar cancer center

Ramadi, Al-Anbar Governorate, 10003, Iraq

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hadeel D. Najem, Clinc pharmD

  university of mustansiriyah collage of pharmacy

  STUDY CHAIR

• Nabeel M Talib, MD,Oncology

  Anbar cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CLINICAL PHARMICIST

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 25, 2026
• Study Start: September 7, 2025
• Primary Completion: March 1, 2026
• Study Completion: April 20, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: start one year after publication
• 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."

Locations

IR (1)