MedDataX Logo

Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia

NCT ID: NCT06930859

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2766 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-03

Study Completion Date

2032-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

NCT03822468

Breast Cancer
COMPLETED PHASE2

A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

NCT06625333

HR+HER2- Advanced Breast Cancer
RECRUITING

Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer

NCT05296746

Breast Cancer Stage II
RECRUITING PHASE2

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

NCT06148506

HR+HER2- Advanced Breast Cancer
ACTIVE_NOT_RECRUITING

Implementation Study to Describe and Compare Retention Rate and Adherence to Adjuvant Therapy With Ribociclib With and Without Usage of Mobile Application in Patients With HR+ HER2-negative Stage II and III Breast Cancer in Real-world Practice

NCT06905301

Breast Cancer
RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ribociclib+AI

Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor)

Ribociclib

Intervention Type DRUG

CDK4/6 inhibitor

Letrozole

Intervention Type DRUG

Aromatase inhibitor

Anastrozole

Intervention Type DRUG

Aromatase inhibitor

Monotherapy AI

Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant AI (aromatase inhibitor) monotherapy

Letrozole

Intervention Type DRUG

Aromatase inhibitor

Anastrozole

Intervention Type DRUG

Aromatase inhibitor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ribociclib

CDK4/6 inhibitor

Intervention Type DRUG

Letrozole

Aromatase inhibitor

Intervention Type DRUG

Anastrozole

Aromatase inhibitor

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Investigative Site

Kaluga, Russia, Russia

Site Status RECRUITING

Novartis Investigative Site

Surgut, Tymen Area, Russia

Site Status RECRUITING

Novartis Investigative Site

Arkhangelsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Barnaul, , Russia

Site Status RECRUITING

Novartis Investigative Site

Irkutsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Ivanovo, , Russia

Site Status RECRUITING

Novartis Investigative Site

Izhevsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Kemerovo, , Russia

Site Status RECRUITING

Novartis Investigative Site

Khimky, , Russia

Site Status RECRUITING

Novartis Investigative Site

Krasnoyarsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Moscow, , Russia

Site Status RECRUITING

Novartis Investigative Site

Pyatigorsk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Saransk, , Russia

Site Status RECRUITING

Novartis Investigative Site

Tver', , Russia

Site Status RECRUITING

Novartis Investigative Site

Tyumen, , Russia

Site Status RECRUITING

Novartis Investigative Site

Ufa, , Russia

Site Status RECRUITING

Novartis Investigative Site

Vladikavkaz, , Russia

Site Status RECRUITING

Novartis Investigative Site

Vladivostok, , Russia

Site Status RECRUITING

Novartis Investigative Site

Volgograd, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yaroslavl, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status RECRUITING

Novartis Investigative Site

Yuzhno-Sakhalinsk, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Novartis Pharmaceuticals

Role: CONTACT

[email protected]
+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLEE011O1RU02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer
NCT03081234 WITHDRAWN PHASE3
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
NCT03839823 COMPLETED PHASE2
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
NCT03096847 COMPLETED PHASE3
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
NCT02941926 COMPLETED PHASE3
A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer
NCT06075758 RECRUITING
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
NCT03078751 COMPLETED PHASE2
Ribociclib in Combination With Adjuvant Endocrine Therapy for Patients With Early High-risk HR+HER2- Breast Cancer
NCT06587789 RECRUITING
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
NCT05827081 RECRUITING PHASE3
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
NCT04943497 COMPLETED
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
NCT07164976 NOT_YET_RECRUITING PHASE1/PHASE2
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
NCT05697146 ACTIVE_NOT_RECRUITING
A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer at High Risk of Recurrence
NCT06830720 RECRUITING
Phase IB & II Study of Ribociclib With Trastuzumab Plus Letrozole in Postmenopausal HR+, HER2+ Advanced Breast Cancer Patients
NCT03913234 UNKNOWN PHASE1/PHASE2
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
NCT01698918 COMPLETED PHASE2
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
NCT06311383 COMPLETED
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
NCT02732119 COMPLETED PHASE1/PHASE2
Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, HR+/HER2- Breast Cancer
NCT05996107 RECRUITING PHASE1
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
NCT05467891 RECRUITING PHASE2
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
NCT03439046 COMPLETED PHASE3
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
NCT03701334 ACTIVE_NOT_RECRUITING PHASE3
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
NCT06375707 RECRUITING PHASE2
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
NCT03555877 COMPLETED PHASE2
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
NCT05870579 RECRUITING PHASE1
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
NCT03477396 COMPLETED PHASE2
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
NCT07054190 RECRUITING PHASE2