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Ribociclib under the microscope: how does it perform in real life?

NCT ID NCT06148506

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 376 people with HR+HER2- advanced breast cancer who are taking ribociclib (Risarg) plus endocrine therapy or chemotherapy as part of their routine care in Russia. The goal is to see how long patients stay on treatment before stopping for any reason. Since this is an observational study, no new treatments are being tested—just real-world outcomes are being tracked.

What this could mean

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

Active substance
Ribociclib (Risarg) combined with endocrine therapy or chemotherapy
What this could lead to
If successful, this study could show how well ribociclib works in everyday practice, potentially guiding better treatment choices for advanced breast cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only includes patients in Russia, which may limit how broadly the findings apply.

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

376 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Jun 2027

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 HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET or combination CT will be enrolled

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. Age ≥ 18 years at the moment of ribociclib+ET or CT initiation. 2. Female/Male gender. 3. Luminal A, Luminal B subtype. 4. Patients with ECOG performance status ≤ 2. 5. Confirmed diagnosis of locally advanced/metastatic not eligible to surgery HR+HER2- BC (de novo) for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL or combination chemotherapy before entering the study in the first line of the treatment. 6. Multiple visceral metastases (including stable CNS mts). 7. Pre-/Pere /postmenopause. 8. Patient who initiated treatment with ribociclib+IA/FUL or combination chemotherapy no longer than 4 weeks (28 days) prior to written informed consent for this study. Exclusion Criteria: 1. Patients with a life expectancy of less than 3 months per the investigator's judgment. 2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study). 3. Patients on active treatment for malignancies other than aBC at the time of enrollment. 4. Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent. 5. Patients with visceral crisis (according to ABC5 definition\*) \*Visceral crisis is defined as severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases but implies important organ compromise leading to a clinical indication for the most rapidly efficacious therapy \[8\]. Examples: Liver visceral crisis: rapidly increasing bilirubin \>1.5 ULN in the absence of Gilbert's syndrome or biliary tract obstruction. Lung visceral crisis: rapidly increasing dyspnoea at rest, not alleviated by drainage of pleural effusion

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Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer

As listed by the trial registrant

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

HR+ / HER2- advanced breast cancer

Contacts and locations

Locations

  • Novartis Investigative Site

    Kaluga, Russia, 248007, Russia

  • Novartis Investigative Site

    Barnaul, 656045, Russia

  • Novartis Investigative Site

    Chelyabinsk, 454087, Russia

  • Novartis Investigative Site

    Irkutsk, 664035, Russia

  • Novartis Investigative Site

    Izhevsk, 426009, Russia

  • Novartis Investigative Site

    Kemerovo, 650036, Russia

  • Novartis Investigative Site

    Krasnodar, 350040, Russia

  • Novartis Investigative Site

    Krasnoyarsk, 660022, Russia

  • Novartis Investigative Site

    Moscow, 115304, Russia

  • Novartis Investigative Site

    Moscow, 115522, Russia

  • Novartis Investigative Site

    Moscow, 143423, Russia

  • Novartis Investigative Site

    Nal'chik, 360051, Russia

  • Novartis Investigative Site

    Podolsk, 142110, Russia

  • Novartis Investigative Site

    Saransk, 430032, Russia

  • Novartis Investigative Site

    Tambov, 392000, Russia

  • Novartis Investigative Site

    Tver', 170008, Russia

  • Novartis Investigative Site

    Ufa, 450054, Russia

  • Novartis Investigative Site

    Vladikavkaz, 362002, Russia

  • Novartis Investigative Site

    Yaroslavl, 150054, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620036, Russia

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