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HR+HER2- Advanced Breast CancerValerEENCT06148506

A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - aBC in Routine Clinical Practice in the Russia

An observational study of HR+HER2- Advanced Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is а prospective, non-interventional, primary data collection cohort study to evaluate the clinical outcomes of the combination of ribociclib + ET and combination chemotherapy in the real-life setting in Russia. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
HR+HER2- Advanced Breast Cancer
What is being tested?
Ribociclib and Combination chemotherapy
How many people
376 participants
Where
20 sitesRussia
Study dates
28 Dec 2023to 30 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Age ≥ 18 years at the moment of ribociclib+ET or CT initiation.
  • Female/Male gender.
  • Luminal A, Luminal B subtype.
  • Patients with ECOG performance status ≤ 2.
  • 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.
  • Multiple visceral metastases (including stable CNS mts).
  • Pre-/Pere /postmenopause.
  • 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.

Who cannot join

  • Patients with a life expectancy of less than 3 months per the investigator's judgment.
  • 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).
  • Patients on active treatment for malignancies other than aBC at the time of enrollment.
  • Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Russia20 sites

  • Novartis Investigative Site

    Barnaul, 656045

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Irkutsk, 664035

  • Novartis Investigative Site

    Izhevsk, 426009

  • Novartis Investigative Site

    Kaluga, Russia, 248007

  • Novartis Investigative Site

    Kemerovo, 650036

  • Novartis Investigative Site

    Krasnodar, 350040

  • Novartis Investigative Site

    Krasnoyarsk, 660022

  • Novartis Investigative Site

    Moscow, 115304

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Moscow, 143423

  • Novartis Investigative Site

    Nal'chik, 360051

  • Novartis Investigative Site

    Podolsk, 142110

  • Novartis Investigative Site

    Saransk, 430032

  • Novartis Investigative Site

    Tambov, 392000

  • Novartis Investigative Site

    Tver', 170008

  • Novartis Investigative Site

    Ufa, 450054

  • Novartis Investigative Site

    Vladikavkaz, 362002

  • Novartis Investigative Site

    Yaroslavl, 150054

  • Novartis Investigative Site

    Yekaterinburg, 620036

Other trials in Russia

About this study

Official title: A Prospective NIS to Evaluate the Clinical Outcomes of Risarg® (Ribociclib) Combined With Endocrine Therapy or Chemotherapy in Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in the Russian Federation

This is а prospective, non-interventional, primary data collection cohort study to evaluate the clinical outcomes of the combination of ribociclib + ET and combination chemotherapy in the real-life setting in Russia. This study is observational in nature; it does not impose a therapy, diagnostic/therapeutic interventions or a visit schedule.

Read the detailed description

Patients with HR+HER2- advanced breast cancer that initiated treatment with ribociclib+ET or combination CT will be enrolled. Approximately, 188 patients will be included into each treatment cohort of the study across different study sites in the Russian Federation and will be assigned to one of the below treatment arms:

  • Ribociclib arm: ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients (N = 188)
  • Combination chemotherapy arm: physician's choice (N = 188) The study will consist of pre-index period, index date and follow up period. Retrospective data will be collected as such: Medical history, previous treatment for Breast cancer (neoad'uvant and ad'uvant if applicable).In this study an index date is defined as a start of ribociclib+ET or chemotherapy treatment. Post-index follow-up period is 24 months or Progressive disease.

Patients will attend the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. No additional diagnostic or monitoring procedures will be applied to the patients and epidemiological methods shall be used for the analysis of collected data. Available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. Patients enrolled in the study will be followed up until death or study close whichever occurs first.

Being tested
Ribociclib, Combination chemotherapy
Keywords
HR+HER2- advanced breast cancer,, ribociclib+ET,, Chemotherapy, ribociclib, NIS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibOther

    Also called Risarg

    There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with ribociclib+ET by prescription within the study enrollment timeline will be recruited.

  • Combination chemotherapyOther

    There is no treatment allocation. Participants with HR+HER2- aBC that initiated treatment with CT by prescription within the study enrollment timeline will be recruited.

Study groups in NCT06148506
Study groupRoleWhat they receive
Ribociclib Armribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients
Receives: Other: Ribociclib
Combination chemotherapyThe choice of which chemotherapy combination used on study is decided by the physician
Receives: Other: Combination chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to treatment failure (TTF)

    The primary efficacy endpoint of the study is time to treatment failure (TTF) in in RIB + ET (AI/FUL) and combination chemotherapy cohorts. Time to treatment failure (TTF) is defined as the time from initiation of treatment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.

    Measured: Up to 24 months

Secondary outcomes (9)

  1. Number of participants by menopausal status

    Number of participants premenopausal, perimenopausal ad postmenopausal at baseline.

    Measured: Baseline

  2. Number of participants by HER2 status

    Number of participants by HER2 status (HER2 receptor positive/negative)

    Measured: Baseline

  3. Number of participants by tumor, nodes and metastasis (TNM) stage

    Number of participants by tumor, nodes and metastasis (TNM) stage

    Measured: Baseline

  4. Chemotherapy regimens

    Percentage of patients receiving different combination chemotherapy regimens.

    Measured: Up to 24 months

  5. Time to treatment failure (TTF) in the subgroups

    Time to treatment failure in HR+HER2- aBC patients in RIB+ET and combination chemotherapy cohorts (in the subgroups Disease-free interval (DFI) ≤ 12 month, DFI > 12 month, Pre- and post menopause).

    Disease-free interval (DFI) will be calculated as the time from the date of diagnosis until the date of first recurrence/progression.

    Measured: Dec2027

  6. Objective response rate (ORR)

    Objective response rate (ORR) as assessed by the investigator. Objective response rate (ORR) is the proportion of patients with a best overall response of Complete Response or Partial Response.

    Measured: Up to 24 months

  7. Clinical benefit rate (CBR)

    Clinical benefit rate (CBR) as assessed by the investigator. Clinical benefit rate (CBR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR) , or an overall lesion response of Stable Disease or Non-CR/Non-PD which lasts for a minimum time duration (with a default of at least 24 weeks in breast cancer studies).

    Measured: Up to 24 months

  8. Time to onset of response (TTR)

    Time to onset of response (TTR) as assessed by the investigator. Time to onset of response (TTR) is defined as the time from the date of randomization to the first documented response of either CR or PR, which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR are based on tumor response data as per local review.

    Measured: Up to 24 months

  9. Assessment of Quality of life - EQ-5D-5L

    Quality of life (EQ-5D-5L) during treatment with ribociclib + ET (AI/FUL) and combination chemotherapy is measured, if used in real practice.

    The scale measures quality of life on a 5-component scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2023
  2. Study start28 Dec 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
376 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06148506
Sponsor's protocol ID
CLEE011ARU04
Acronym
ValerEE
Status last verified
Nov 2025
First submitted
20 Nov 2023
Last updated
5 Dec 2025
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HR+HER2- Advanced Breast Cancer, run by Novartis Pharmaceuticals at 20 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to treatment failure (TTF) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06148506.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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