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Real-World study tracks breast cancer drug performance outside the lab

NCT ID NCT07243002

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study is observing 3,000 people with early-stage HR+/HER2- breast cancer who are taking ribociclib or abemaciclib as part of their routine care. Researchers will look at how long patients stay cancer-free, how well they stick to their medication, and their quality of life. The goal is to understand how these drugs work in real-world settings, not just in controlled clinical trials.

What this could mean

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

Active substance
ribociclib and abemaciclib (CDK4/6 inhibitors)
What this could lead to
If successful, this could provide real-world evidence on how well these drugs work and are tolerated outside of clinical trials.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient selection and other factors. It does not 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

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Apr 2030

An estimate. End dates often move.

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

Patients with early breast cancer stage II or III, ER+ or PR+ (or both) and HER2-, treated per standard of care with ribociclib plus Endocrine Therapy (N=2650) or abemaciclib plus Endocrine Therapy (N=250).

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: * Males or females. * Diagnosed with breast cancer, as defined by the International Classification of Diseases (ICD), 9th or 10th Revision, Clinical Modification (ICD-9-CM 174.xx, 175.xx/ICD-10-CMC50.xx). * Aged ≥18 years (or local legal age of consent) at the date of initial breast cancer diagnosis. * Patients with anatomic staging II and III as determined using American Joint Committee on Cancer (AJCC) Criteria. * Have initiated adjuvant therapy with ribociclib or abemaciclib, per the approved local label, in combination with ET (within 14 days prior to enrollment). * Have HR+ status, as determined by the closest biomarker test on or before the adjuvant therapy initiation date: * Tested positive for estrogen receptor (ER+), or * Tested positive for progesterone receptor (PR+), or * Tested positive for both. * Tested negative for HER2 (HER2-) using the closest biomarker test on or before the adjuvant therapy initiation date. Exclusion Criteria: * Patients with local or distant breast cancer recurrence before the ribociclib/abemaciclib initiation date. * Patients enrolled in clinical trials (receiving treatment with clinical study drugs in any setting, i.e., neoadjuvant, adjuvant, local/regional, metastatic) during the 12-month baseline period. * Patients physically/mentally incapable of understanding the study requirements or fulfilling data collection instruments and require the support of a legally authorized representative.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    London, SW3 6JJ, United Kingdom

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