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Can a common breast cancer drug work equally well in underrepresented groups?

NCT ID NCT07760714

Knowledge-focused Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study looks back at medical records to see how ribociclib, a CDK4/6 inhibitor used for hormone receptor-positive, HER2-negative metastatic breast cancer, is prescribed and tolerated in older adults (65 and over) and Black/African American patients. These groups are often underrepresented in clinical trials. The goal is to understand real-world treatment patterns, side effects, and effectiveness in these populations, using data from a large U.S. oncology database.

What this could mean

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

Active substance
ribociclib (a CDK4/6 inhibitor)
What this could lead to
If successful, this could reveal whether ribociclib works as well in older and Black patients as in other groups, helping tailor breast cancer care.
What could go wrong
This is a retrospective, observational study, so it cannot prove cause and effect. Results may be limited by data quality and may not apply to all patients.

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

945 people

The number who actually took part.

Started

Feb 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

HR+/HER2- recurrent or mBC cancer patients aged 65 years or older, and who self-identify as African American, and initiated 1L ribociclib plus ET on or after January 01, 2018.

Ages

18 to 120 years

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: 1. Included in Flatiron's mBC Enhanced Data Model (EDM): 1. Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification \[ICD-9-CM\] 174.x or 175.x or ICD, 10th revision, clinical modification \[ICD-10-CM\] C50x) 2. At least two documented clinical visits, on different days, occurring on or after January 1, 2011 3. Included in probabilistic sample of patients queued for review via abstraction 4. Had pathology consistent with breast cancer 5. Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease 2. Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy \[ET\]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations 3. Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib 4. Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024 Exclusion Criteria: 1. Use of any CDK4/6 inhibitor therapy in combination with tamoxifen 2. Use of any CDK4/6 inhibitor in the pre-metastatic setting

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Novartis

    East Hanover, New Jersey, 07936, United States

More trials for these conditions

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