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New study tests ribociclib combo to stop breast cancer return

NCT ID NCT06930859

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times

Summary

This study looks at how well ribociclib, a targeted cancer drug, works when added to hormone therapy for people with HR+ HER2- stage II or III breast cancer. It will follow about 2,766 patients in Russia, comparing those who get ribociclib plus hormone therapy to those who got hormone therapy alone in the past. The goal is to see if the combination helps prevent the cancer from coming back.

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) combined with hormone therapy (letrozole or anastrozole)
What this could lead to
If successful, this could show that adding ribociclib to standard hormone therapy helps prevent breast cancer from coming back in people with HR+ HER2- stage II or III cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It's also early in real-world use, and side effects like low blood cell counts or liver issues are possible with ribociclib.

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 2,766 people

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

Started

Dec 2025

Expected to finish

Dec 2032

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- stage II-III breast cancer receiving adjuvant therapy with ribociclib combined with AI will be include in prospective cohort. Patients with HR+HER2- stage II-III breast cancer receiving adjuvant therapy with AI alone will be included in retrospective cohort.

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: Patients from the prospective cohort of the study must meet all of the following criteria: 1. Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists). 2. Age ≥18 years at the time of signing the ICF. 3. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out. 4. The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib. 5. ECOG performance status 0-1 Patients from the retrospective cohort of the study must meet all of the following criteria: 1. Age ≥18 years at the initiation of hormone therapy. 2. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out. 3. Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020. 4. Presence of the necessary information in the source documentation. Exclusion Criteria: Patients enrolled in the study in prospective cohort should not meet any of the following criteria. 1. History of therapy with abemaciclib or palbociclib 2. Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form 3. Active therapy for other malignant neoplasms 4. Participation in interventional clinical studies at the time of signing the Informed Consent Form Patients enrolled in the study in retrospective cohort should not meet any of the following criteria. 1. Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors 2. A history of another concomitant malignant neoplasm requiring active therapy 3. Participation in interventional clinical studies at the time of treatment for breast cancer 4. Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.

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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

    42 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

    Sochi, Russian Federation, 354057, Russia

  • Novartis Investigative Site

    RECRUITING

    Kaluga, Russia, 248007, Russia

  • Novartis Investigative Site

    RECRUITING

    Pskov, Russia, 180000, Russia

  • Novartis Investigative Site

    RECRUITING

    Ryazan, Russia, 390011, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, Russia, 197758, Russia

  • Novartis Investigative Site

    RECRUITING

    Surgut, Tymen Area, 628402, Russia

  • Novartis Investigative Site

    RECRUITING

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    RECRUITING

    Barnaul, 656045, Russia

  • Novartis Investigative Site

    RECRUITING

    Bryansk, 241028, Russia

  • Novartis Investigative Site

    RECRUITING

    Irkutsk, 664035, Russia

  • Novartis Investigative Site

    RECRUITING

    Ivanovo, 153040, Russia

  • Novartis Investigative Site

    RECRUITING

    Izhevsk, 426009, Russia

  • Novartis Investigative Site

    RECRUITING

    Kemerovo, 650036, Russia

  • Novartis Investigative Site

    RECRUITING

    Khabarovsk, 680042, Russia

  • Novartis Investigative Site

    RECRUITING

    Khanty-Mansiysk, 628012, Russia

  • Novartis Investigative Site

    RECRUITING

    Khimky, 121552, Russia

  • Novartis Investigative Site

    RECRUITING

    Kirov, 610021, Russia

  • Novartis Investigative Site

    RECRUITING

    Krasnoyarsk, 660022, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 115304, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 115522, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 125284, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow, 129110, Russia

  • Novartis Investigative Site

    RECRUITING

    Moscow Region Balas, 143900, Russia

  • Novartis Investigative Site

    RECRUITING

    Perm, 614066, Russia

  • Novartis Investigative Site

    RECRUITING

    Pyatigorsk, 357502, Russia

  • Novartis Investigative Site

    RECRUITING

    Rostov-on-Don, 344006, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, 194017, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, 194291, Russia

  • Novartis Investigative Site

    RECRUITING

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    RECRUITING

    Saransk, 430032, Russia

  • Novartis Investigative Site

    RECRUITING

    Saratov, 410053, Russia

  • Novartis Investigative Site

    RECRUITING

    Sestroretsk, 197706, Russia

  • Novartis Investigative Site

    RECRUITING

    Tver', 170008, Russia

  • Novartis Investigative Site

    RECRUITING

    Tyumen, 625023, Russia

  • Novartis Investigative Site

    RECRUITING

    Ufa, 450054, Russia

  • Novartis Investigative Site

    RECRUITING

    Vladikavkaz, 362002, Russia

  • Novartis Investigative Site

    RECRUITING

    Vladivostok, 690105, Russia

  • Novartis Investigative Site

    RECRUITING

    Volgograd, 400138, Russia

  • Novartis Investigative Site

    RECRUITING

    Voronezh, 394036, Russia

  • Novartis Investigative Site

    RECRUITING

    Yaroslavl, 150054, Russia

  • Novartis Investigative Site

    RECRUITING

    Yekaterinburg, 620036, Russia

  • Novartis Investigative Site

    RECRUITING

    Yuzhno-Sakhalinsk, 693010, Russia

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