NCT06148506

Brief 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. This study is observational in nature; it does not impose a therapy, diagnostic/therapeutic interventions or a visit schedule.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

20 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3.5 years

First QC Date

November 20, 2023

Last Update Submit

November 28, 2025

Conditions

HR+HER2- Advanced Breast Cancer

Keywords

HR+HER2- advanced breast cancer,ribociclib+ET,ChemotherapyribociclibNIS

Outcome Measures

Primary Outcomes (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.

    Up to 24 months

Secondary Outcomes (9)

  • Number of participants by menopausal status

    Baseline

  • Number of participants by HER2 status

    Baseline

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

    Baseline

  • Chemotherapy regimens

    Up to 24 months

  • Time to treatment failure (TTF) in the subgroups

    Dec2027

  • +4 more secondary outcomes

Study Arms (2)

Ribociclib Arm

ribociclib (600 mg, 3 weeks on/1 week off)+ IA/FUL + goserilin for premenopausal patients

Other: Ribociclib

Combination chemotherapy

The choice of which chemotherapy combination used on study is decided by the physician

Other: Combination chemotherapy

Interventions

RibociclibOTHER

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.

Also known as: Risarg
Ribociclib Arm
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.

Combination chemotherapy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Novartis Investigative Site

Kaluga, Russia, 248007, Russia

Location

Novartis Investigative Site

Barnaul, 656045, Russia

Location

Novartis Investigative Site

Chelyabinsk, 454087, Russia

Location

Novartis Investigative Site

Irkutsk, 664035, Russia

Location

Novartis Investigative Site

Izhevsk, 426009, Russia

Location

Novartis Investigative Site

Kemerovo, 650036, Russia

Location

Novartis Investigative Site

Krasnodar, 350040, Russia

Location

Novartis Investigative Site

Krasnoyarsk, 660022, Russia

Location

Novartis Investigative Site

Moscow, 115304, Russia

Location

Novartis Investigative Site

Moscow, 115522, Russia

Location

Novartis Investigative Site

Moscow, 143423, Russia

Location

Novartis Investigative Site

Nal'chik, 360051, Russia

Location

Novartis Investigative Site

Podolsk, 142110, Russia

Location

Novartis Investigative Site

Saransk, 430032, Russia

Location

Novartis Investigative Site

Tambov, 392000, Russia

Location

Novartis Investigative Site

Tver', 170008, Russia

Location

Novartis Investigative Site

Ufa, 450054, Russia

Location

Novartis Investigative Site

Vladikavkaz, 362002, Russia

Location

Novartis Investigative Site

Yaroslavl, 150054, Russia

Location

Novartis Investigative Site

Yekaterinburg, 620036, Russia

Location

MeSH Terms

Interventions

ribociclibDrug Therapy, Combination

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

December 28, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(20)