Brest CancerPALLAS-IRAQNCT07493291
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
An observational study of Brest Cancer and CDK4/6 Inhibitor, run by Al-Mustansiriyah University at 1 site in Iraq.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Brest Cancer, CDK4/6 Inhibitor
- What is being tested?
- Palbociclib (Brand vs Generic) compartive
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteIraq
- Study dates
- 7 Sep 2025to 20 Apr 2026
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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).
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.
- 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.
Exclusion Criteria: 1. Male breast cancer patients, due to a different biology and small population proportion in Iraq.
- 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
-
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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 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.
- Conditions
- Brest Cancer, CDK4/6 Inhibitor
- Being tested
- Palbociclib (Brand vs Generic) compartive
- Keywords
- Comparative study, Drug effectiveness, Brand-name drug, Palbociclib, Stage IV breast cancer, Safety drug
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| • 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (1)
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start7 Sep 2025
- Primary completion1 Mar 2026
- Study completion20 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brest CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Al-Mustansiriyah University
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Anbar Health Organization
- Responsible party
- Principal investigator, Abdullah H Ali, Al-Mustansiriyah University
- Investigators
- Hadeel D. Najem, Clinc pharmD, Study chair, university of mustansiriyah collage of pharmacyNabeel M Talib, MD,Oncology, Principal investigator, Anbar cancer center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493291
- Sponsor's protocol ID
- 110
- Other IDs
- 2025053, 97
- Acronym
- PALLAS-IRAQ
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request."
Publications
Benitez Fuentes JD, Morgan E, de Luna Aguilar A, Mafra A, Shah R, Giusti F, Vignat J, Znaor A, Musetti C, Yip CH, Van Eycken L, Jedy-Agba E, Pineros M, Soerjomataram I. Global Stage Distribution of Breast Cancer at Diagnosis: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jan 1;10(1):71-78. doi: 10.1001/jamaoncol.2023.4837.
PubMed 37943547
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07493291
- Acronym / sponsor ID
- PALLAS-IRAQ / 110
- Conditions
- Brest Cancer, CDK4/6 Inhibitor
- Keywords
- Comparative study, Drug effectiveness, Brand-name drug, Palbociclib, Stage IV breast cancer, Safety drug
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Mustansiriyah UniversityUniversity, hospital or other
- Collaborators
- Al-Anbar Health Organization
- Study start
- 7 Sep 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 20 Apr 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| • Prospective arm for patients currently receiving generic Palbociclib | – | Drug: Palbociclib (Brand vs Generic) compartive• Group B (n=30-50): Currently receiving Palbociclib-IPI (prospective follow-up for at least 3 months) |
| Retrospective arm for patients treated with branded Palbociclib (Ibrance®) | – | –Group A (n=30-50): Received Ibrance® (retrospective data from oncology centers' archives) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palbociclib (Brand vs Generic) compartiveParticipants 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. | Drug | • Prospective arm for patients currently receiving generic Palbociclib |
Primary outcome
The primary efficacy endpoint is defined as progression free survival (PFS)
Time frame: two years
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.
1 secondary outcome
Secondary efficacy endpoints used include overall response rate (ORR)
Time frame: two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 37943547Benitez Fuentes JD, Morgan E, de Luna Aguilar A, Mafra A, Shah R, Giusti F, Vignat J, Znaor A, Musetti C, Yip CH, Van Eycken L, Jedy-Agba E, Pineros M, Soerjomataram I. Global Stage Distribution of Breast Cancer at Diagnosis: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jan 1;10(1):71-78. doi: 10.1001/jamaoncol.2023.4837.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadeel D. Najem, Clinc pharmD study chair
university of mustansiriyah collage of pharmacy
Nabeel M Talib, MD,Oncology principal investigator
Anbar cancer center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brest Cancer and CDK4/6 Inhibitor, run by Al-Mustansiriyah University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint is defined as progression free survival (PFS) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07493291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.