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Can electronic health records replicate Gold-Standard cancer trials?

NCT ID NCT07178743

Knowledge-focused Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study looked at over 6,000 people with advanced breast cancer to see if information from electronic health records could match the results of a famous clinical trial called PALOMA-2. The goal was not to test a new drug, but to learn whether real-world data can be trusted to answer important medical questions. Researchers compared patients who started a combination of palbociclib and letrozole against those who started letrozole alone.

What this could mean

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

What this could lead to
If successful, this could show that real-world data can reliably reproduce clinical trial results, potentially speeding up future research.
What could go wrong
This is an observational emulation, not a new treatment test. It may not perfectly match the original trial's findings due to data limitations.

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

6,097 people

The number who actually took part.

Started

Jul 2025

Finished

Mar 2026

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

Postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer who receive treatment without curative intent

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.

Study Period: ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 3 (EDB3): Follow-up information through June 2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023. Inclusion Criteria: * Age ≥18 years * Postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer who receive treatment without curative intent * The line of therapy for patients in EDB1 and EDB3 is implicitly advanced/metastatic because the line of therapy classification starts after their advanced/metastatic diagnosis in the respective database * In EDB4, patients must explicitly have any evidence of a metastasis prior initiating palbociclib plus letrozole or letrozole alone * Adenocarcinoma histology * No prior systemic treatment for advanced/metastatic disease * ECOG performance status of 0 or 1 Exclusion Criteria: * HER2+ * CNS metastases * Prior treatment with CDK4/6 inhibitor * Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix * Systemic anticancer therapy other than palbocicilib or letrozole * Treatment with non-steroidal aromatase inhibitor (i.e.anastrozole, letrozole)

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Conditions

The condition(s) this trial relates to.

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 breast cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

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