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Cheaper generic breast cancer drug put to the test

NCT ID NCT07493291

Disease control Sponsor: Al-Mustansiriyah University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares the brand-name drug Ibrance (palbociclib) with a local generic version in 100 Iraqi women with stage IV hormone receptor-positive, HER2-negative breast cancer. The goal is to see if the generic works just as well and is as safe as the brand. Patients take the drug along with standard hormone therapy, and researchers track how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
palbociclib (brand-name Ibrance vs generic)
What this could lead to
If the generic works as well as the brand, it could offer a more affordable treatment option for advanced breast cancer patients.
What could go wrong
This is a small, single-country study with 100 patients, so results may not apply broadly. Generic formulations may vary in quality or effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \-

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brest cancer CDK4/6 inhibitor

Contacts and locations

Locations

  • Anbar cancer center

    Ramadi, Al-Anbar Governorate, 10003, Iraq

More trials for these conditions

Other studies related to the condition(s) this trial covers.