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Real-World study tracks Ribociclib's impact on early breast cancer

NCT ID NCT06797531

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Updated 3 times

Summary

This study follows 177 people with HR+/HER2- early breast cancer who are already taking ribociclib with hormone therapy as part of their routine care. Researchers will track how well the treatment works and any side effects over time. The goal is to see if the drug helps prevent cancer from coming back in a real-world setting.

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 targeted cancer drug)
What this could lead to
If successful, this study could confirm that ribociclib combined with hormone therapy works well in real-world settings, potentially improving outcomes for people with HR+/HER2- early breast cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also limited to a specific population in Saudi Arabia, so findings may not apply broadly.

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 177 people

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

Started

Aug 2025

Expected to finish

Nov 2028

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

HR+/HER2- early breast cancer in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.

Ages

18 to 99 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. Signed and dated Patient Informed Consent Form (PICF) obtained. 2. The patient is ≥ 18 years-old at the time of PICF signature. 3. Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC. 4. Male or female patients with HER2- BC. 5. Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date. 6. Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC. 7. Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male. Exclusion Criteria: 1. Ribociclib-based treatment regimen beyond adjuvant therapy for EBC. 2. Patients are currently participating in any other clinical trials. 3. Patients who previously received any other CDK4/6 inhibitor. 4. Patients who refused to sign informed consent. 5. According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

HR+/HER2- early 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

    2 sites. 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

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    RECRUITING

    Riyadh, 11426, Saudi Arabia

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