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Real-World study tracks ribociclib combo in elderly breast cancer

NCT ID NCT06625333

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 329 older patients (65 years and up) with HR+HER2- advanced breast cancer who are taking ribociclib combined with endocrine therapy as their first or second treatment. Researchers are tracking quality of life, treatment effectiveness, and safety in real-world clinics across Russia. The goal is to see how well this therapy works in everyday practice for this age group.

What this could mean

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

Active substance
ribociclib combined with endocrine therapy (aromatase inhibitor or fulvestrant)
What this could lead to
If successful, this could help doctors understand how well this treatment works and affects quality of life in older patients, leading to better care for this age group.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors other than the treatment. It only includes patients in Russia, so findings may not apply elsewhere.

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

329 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Dec 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

elderly patients with HR+HER2- advanced breast cancer

Ages

65 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 ≥ 65 years at the moment of ribociclib+ET initiation 2. Female/Male gender 3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment 4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study 5. Provision of written informed consent. 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 within 3 years before BC diagnosis 4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).

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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

    Arkhangelsk, 163045, Russia

  • Novartis Investigative Site

    Barnaul, 656045, Russia

  • Novartis Investigative Site

    Bryansk, 241028, Russia

  • Novartis Investigative Site

    Chelyabinsk, 454080, Russia

  • Novartis Investigative Site

    Irkutsk, 664035, Russia

  • Novartis Investigative Site

    Kemerovo, 650036, Russia

  • Novartis Investigative Site

    Khabarovsk, 680042, Russia

  • Novartis Investigative Site

    Khanty-Mansiysk, 628012, Russia

  • Novartis Investigative Site

    Kirov, 610021, Russia

  • Novartis Investigative Site

    Krasnoyarsk, 660022, Russia

  • Novartis Investigative Site

    Obninsk, 249036, Russia

  • Novartis Investigative Site

    Perm, 614066, Russia

  • Novartis Investigative Site

    Rostov-on-Don, 344006, Russia

  • Novartis Investigative Site

    Saint Petersburg, 194291, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    Tambov, 392000, Russia

  • Novartis Investigative Site

    Tver', 170008, Russia

  • Novartis Investigative Site

    Ufa, 450054, Russia

  • Novartis Investigative Site

    Yaroslavl, 150054, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620036, Russia

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