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Can Real-World data replace clinical trials? new study puts it to the test

NCT ID NCT07225790

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at whether information from routine medical records can produce the same results as a gold-standard clinical trial. Researchers analyzed data from 3,883 women with advanced breast cancer to see if real-world analyses could match the findings of the MONARCH-3 trial, which tested a drug combination. The goal is to learn when real-world data can be trusted for future research.

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, making future research faster and cheaper.
What could go wrong
This is an observational study, not a new treatment test. Results may not perfectly match the original trial due to differences in patient care and data quality.

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

3,883 people

The number who actually took part.

Started

Nov 2025

Finished

Jan 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/PR-positive, HER2-negative locally advanced or metastatic breast cancer who receive treatment without curative intent

Ages

18 years and older

Sex

Female participants only

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: * Female aged ≥18 years at treatment initiation from 2017 - 2023 * Evidence of metastatic breast cancer (MBC) * Documentation of Estrogen/Progesterone receptor-positive (ER/PR+) * Documentation of Human Epidermal Growth Factor Receptor Negative (HER2-) * ECOG performance status of 0 or 1 within 90 days of index date Exclusion Criteria: * CNS metastases * Prior treatment with CKD4/6 inhibitor * Prior or current treatment with chemotherapy or endocrine therapy other than letrozole/anastrozole for systemic anticancer therapy for MBC. * Prior (neo-)adjuvant endocrine therapy * Systemic anticancer therapy other than abemaciclib or letrozole/anastrozole * Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma

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.