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Scientists check if Real-World records can mimic Gold-Standard cancer trial

NCT ID NCT07274709

Knowledge-focused Sponsor: Shirley Vichy Wang Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at whether information from routine medical records (real-world data) can produce the same results as a carefully controlled clinical trial called MONALEESA-2 for advanced breast cancer. Researchers analyzed data from over 2,400 patients to see if they could reliably measure survival times. The goal is to learn when real-world data can be trusted for future research, not to test a new treatment.

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

2,495 people

The number who actually took part.

Started

Sep 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 hormone receptor (HR)-positive \[estrogen receptor (ER) and/or progesterone receptor (PR)\], human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.

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 through 2017 to 2023 * Metastatic breast cancer * Hormone receptor positive (ER/PR+) * Untreated with systemic anticancer therapy for advanced disease * ECOG performance status of 0 or 1 * HER2-negative Exclusion Criteria: * Prior treatment with CDK4/6 inhibitor * Locally advanced (unresectable) or inflammatory breast cancer * Non-breast cancer malignancy other than basal/squamous cell skin cancer or carcinoma in situ of cervix * Prior adjuvant therapy for breast cancer * Systemic anticancer therapy other than ribociclib or letrozole

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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.