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Large database study probes lung risk of common breast cancer drug

NCT ID NCT07096024

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at the risk of interstitial lung disease (ILD) in people with inoperable or recurrent breast cancer who take the drug palbociclib (Ibrance) combined with fulvestrant. Researchers will compare this group to patients taking fulvestrant alone, using data from over 400 hospitals in Japan. The goal is to understand whether palbociclib increases the chance of ILD and what factors might make someone more vulnerable.

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) plus fulvestrant
What this could lead to
If successful, this could help doctors understand the risk of lung inflammation (interstitial lung disease) in breast cancer patients treated with palbociclib, leading to safer use.
What could go wrong
This is an observational study using existing medical records, not a controlled trial. It can show associations but cannot prove cause and effect. Results may be influenced by unmeasured factors.

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

95,637 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2025

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

The source population comprises patients diagnosed with breast cancer that include newly treated with palbociclib and/or other endocrine-based therapies for inoperable or recurrent breast cancer between 25 November 2011 and 31 December 2024

Ages

15 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.

Inclusion Criteria: * Having prescription records of drugs for endocrine therapy (aromatase inhibitors, SERDs, SERMs, and CDK4/6 inhibitors) from 25 November 2011 to 31 December 2024. * Having any breast cancer records with definitive diagnosis in the same month as the first prescription date. * Having any records in MDV database on or before 6 months prior to the first prescription date (\<= -180 days: first prescription date = 0 day). * Having any records in MDV database within 6 months prior to the first prescription date (-180 days to 0 day). Exclusion Criteria: * Having any records of anti-HER2 medication (e.g., trastuzumab, pertuzumab, lapatinib or trastuzumab emtansine) from 25 November 2011 to 31 December 2024. * Having any records of second primary cancer with definitive diagnosis

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast neoplasms

Contacts and locations

Locations

  • Pfizer

    New York, New York, 10001, United States

More trials for these conditions

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