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Russian breast cancer study reveals Real-World treatment patterns

NCT ID NCT04943497

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 4 times

Summary

This study observed over 2,400 women in Russia with advanced HR+/HER2- breast cancer to see how well different treatments work in everyday medical practice. Researchers tracked how long patients stayed on their therapy before it stopped working or caused side effects. The goal was to understand real-world outcomes, not to test a new drug.

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

2,390 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2025

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

Women with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, monoET or CT within the study enrollment timeline were provided by national oncology centers and hospitals that were selected based on their experience in treating Breast Cancer.

Ages

18 to 99 years

Sex

Female participants only

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, alpelisib, monoET or CT treatment initiation. 2. Female gender. 3. Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physicial took the decision to initiate treatment with ribociclib, alpelisib, monoET or CT before entering the study. 4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longer than 4 weeks (28 days) prior to written informed consent for this study. 5. Patients with ECOG performance status ≤ 2. 6. Provision of written informed consent. Exclusion Criteria: 1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosis 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 trial or NIS can be included as long as their standard of care is not altered by the study). 3. Patients receiving active treatment for malignancies other than BC at the time of enrollment. 4. Patients who are unable to understand the nature of the study.

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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 Investigative Site

    Syktyvkar, Komi, 167904, Russia

  • Novartis Investigative Site

    Sochi, Russian Federation, 354057, Russia

  • Novartis Investigative Site

    Surgut, Tymen Area, 628402, Russia

  • Novartis Investigative Site

    Barnaul, 656045, Russia

  • Novartis Investigative Site

    Belgorod, 308010, Russia

  • Novartis Investigative Site

    Bryansk, 241028, Russia

  • Novartis Investigative Site

    Cheboksary, 428020, Russia

  • Novartis Investigative Site

    Chelyabinsk, 454087, Russia

  • Novartis Investigative Site

    Cherkessk, 369000, Russia

  • Novartis Investigative Site

    Chita, 672027, Russia

  • Novartis Investigative Site

    Irkutsk, 664035, Russia

  • Novartis Investigative Site

    Ivanovo, 153040, Russia

  • Novartis Investigative Site

    Izhevsk, 426009, Russia

  • Novartis Investigative Site

    Kaliningrad, 236016, Russia

  • Novartis Investigative Site

    Kaluga, 248007, Russia

  • Novartis Investigative Site

    Khabarovsk, 680042, Russia

  • Novartis Investigative Site

    Khanty-Mansiysk, 628012, Russia

  • Novartis Investigative Site

    Kirov, 610021, Russia

  • Novartis Investigative Site

    Kostroma, 156005, Russia

  • Novartis Investigative Site

    Krasnodar, 350040, Russia

  • Novartis Investigative Site

    Krasnoyarsk, 660022, Russia

  • Novartis Investigative Site

    Moscow, 105005, Russia

  • Novartis Investigative Site

    Moscow, 111123, Russia

  • Novartis Investigative Site

    Moscow, 115304, Russia

  • Novartis Investigative Site

    Moscow, 115522, Russia

  • Novartis Investigative Site

    Moscow, 129110, Russia

  • Novartis Investigative Site

    Moscow, 143423, Russia

  • Novartis Investigative Site

    Moscow Region Balas, 143900, Russia

  • Novartis Investigative Site

    Nal'chik, 360051, Russia

  • Novartis Investigative Site

    Nizhny Novgorod, 603081, Russia

  • Novartis Investigative Site

    Novosibirsk, 630108, Russia

  • Novartis Investigative Site

    Odintsovo, 143003, Russia

  • Novartis Investigative Site

    Omsk, 644013, Russia

  • Novartis Investigative Site

    Perm, 614066, Russia

  • Novartis Investigative Site

    Podolsk, 142110, Russia

  • Novartis Investigative Site

    Pyatigorsk, 357502, Russia

  • Novartis Investigative Site

    Rostov-on-Don, 344006, Russia

  • Novartis Investigative Site

    Saint Petersburg, 191104, Russia

  • Novartis Investigative Site

    Saint Petersburg, 194214, Russia

  • Novartis Investigative Site

    Saint Petersburg, 197758, Russia

  • Novartis Investigative Site

    Saransk, 430032, Russia

  • Novartis Investigative Site

    Saratov, 410053, Russia

  • Novartis Investigative Site

    Sestroretsk, 197706, Russia

  • Novartis Investigative Site

    Sevastopol’, 299045, Russia

  • Novartis Investigative Site

    Severodvinsk, 450054, Russia

  • Novartis Investigative Site

    Simferopol, 295023, Russia

  • Novartis Investigative Site

    Tambov, 392000, Russia

  • Novartis Investigative Site

    Tula, 300040, Russia

  • Novartis Investigative Site

    Tver', 170008, Russia

  • Novartis Investigative Site

    Tyumen, 625041, Russia

  • Novartis Investigative Site

    Ufa, 450054, Russia

  • Novartis Investigative Site

    Vladikavkaz, 362002, Russia

  • Novartis Investigative Site

    Vladivostok, 690105, Russia

  • Novartis Investigative Site

    Voronezh, 394036, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620027, Russia

  • Novartis Investigative Site

    Yekaterinburg, 620036, Russia

  • Novartis Investigative Site

    Yuzhno-Sakhalinsk, 693010, Russia

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