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Real-World data sheds light on ribociclib use in early breast cancer

NCT ID NCT07710716

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study looks at how the drug ribociclib is actually used in everyday medical practice for people with a common type of early breast cancer (HR+/HER2-). Researchers will analyze medical records from thousands of patients to see who gets the drug, how long they take it, and what side effects occur. The goal is to understand real-world treatment patterns and safety, not to test if the drug works.

What this could mean

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

Active substance
ribociclib
What this could lead to
If successful, this study could provide valuable insights into how ribociclib is used in everyday clinical practice, helping doctors optimize treatment for early breast cancer patients.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by differences in patient care across countries.

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

Apr 2026

Expected to finish

Sep 2026

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

Adult patients diagnosed with HR+/HER2- eBC who have undergone surgical resection of the primary breast tumor and initiated adjuvant ET.

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: 1. Evidence of diagnosis of eBC during the identification period. 2. Aged ≥18 years at index diagnosis date. The index diagnosis date is the date of first diagnosis of eBC. 3. Anatomic stage I-III breast cancer (BC) per American Joint Committee on Cancer (AJCC), 8th Edition at index diagnosis date. 4. Evidence of HR+ during the study period: 1. have tested positive for estrogen receptor (ER+), or 2. have tested positive for progesterone receptor (PR+), or 3. have tested positive for both. 5. Tested negative for HER2 (HER2-) during the study period. 6. Evidence of surgical resection of the primary breast tumor at any time. 7. Received endocrine therapy (ET) in the adjuvant setting after index diagnosis date. Exclusion criteria: 1. Evidence of another secondary malignancy at any time prior to index diagnosis date. 2. Evidence of other primary cancer (except for skin cancer) at any time prior to index diagnosis date. 3. Patients who participate in an interventional clinical trial at any time prior to or during the study period. 4. Patients with severely incomplete or inconsistent data, precluding validity of results. Other protocol-defined inclusion/exclusion criteria may apply.

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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

    Basel, 4056, Switzerland

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