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Real-World data reveals how breast cancer patients fare after initial therapy

NCT ID NCT06975371

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This completed study analyzed data from 1,415 patients with HR-positive, HER2-negative metastatic breast cancer in the United States. Researchers looked at what happened after patients progressed on their first-line treatment (endocrine therapy plus a CDK4/6 inhibitor) and started a second-line therapy. The goal was to understand real-world progression-free survival and overall survival using the Flatiron Health Database.

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

1,415 people

The number who actually took part.

Started

Apr 2025

Finished

Aug 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 study cohort consists of adults in the Flatiron database who are diagnosed with HR+/HER2- mBC and initiated a subsequent LOT (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i.

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.

Inclusion criteria * Patients with evidence of Stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2017 * Aged ≥18 years at mBC diagnosis date * Received 1L ET + CDK 4/6i, with no other systemic agents, in the metastatic setting * Had evidence of a rwP event during 1L ET + CDK 4/6i * Evidence of a subsequent LOT following 1L ET + CDK 4/6i (start date of subsequent LOT = index treatment date) * A record of HR+ status in the closest estrogen receptor (ER) or progesterone receptor (PR) test result occurring prior to or within 30 days after the index treatment date * A record of HER2- status in the closest HER2 test result recorded prior to or on the index treatment date * Index treatment date occurring at least 90 days prior to end of study period (30Sep2024) Exclusion Criteria • A record of estrogen receptor 1 (ESR1), phosphatidylinositol4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA), V-akt murine thymoma viral oncogene homolog (AKT1), phosphatase and tensin homolog (PTEN), or germline breast cancer gene (gBRCA) alteration/mutation prior to or within 30 days after index treatment date

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Conditions

The condition(s) this trial relates to.

breast neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

Advanced/metastatic HER2-negative breast cancer

Contacts and locations

Locations

  • Flatiron Health, Inc

    New York, New York, 10013, United States

More trials for these conditions

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