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How do breast cancer drugs work in real life? new study digs into medical records

NCT ID NCT06495164

Knowledge-focused Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how Palbociclib and other CDK4/6 inhibitors are actually used in patients with a common type of advanced breast cancer (HR+/HER2-). Researchers will analyze anonymous medical records from routine care to see how long patients stay on treatment and whether it delays the need for chemotherapy. The goal is to understand real-world effectiveness, not to test a new drug.

What this could mean

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

Active substance
Palbociclib (Ibrance), other CDK4/6 inhibitors (Ribociclib, Abemaciclib), and aromatase inhibitors (letrozole, anastrozole, exemestane)
What this could lead to
If successful, this study could provide a clearer picture of how these drugs work in everyday practice, potentially guiding better treatment decisions for patients with this type of breast cancer.
What could go wrong
This is an observational study using existing medical records, not a controlled trial. Results may be influenced by missing data or patient selection, and cannot prove cause and effect.

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 1 person

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

Started

Jun 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Flatiron Health Database is a longitudinal, demographically, and geographically diverse dataset derived from EHR data from over 280 cancer clinics (\~800 sites of care) including more than 3.0 million active US cancer patients available for analysis. This study uses secondary de-identified Flatiron Health data that involve men and women who had been diagnosed with HR+/HER2-MBC in the United States.

Ages

18 years and older

Sex

Anyone

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.

Patients are eligible for the study if they were 18 years of age or older at MBC diagnosis, had HR+/HER2- confirmed and initiated first line therapy (CDK4/6i, ET, CT, or other) in the metastatic setting during the period from February 2015 through June 2022 or data cutoff.

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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.

Breast cancer Malignant neoplasm of breast

Contacts and locations

Locations

  • Pfizer New York

    New York, New York, 10001, United States

More trials for these conditions

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