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

NCT06930859 | Recruiting

• 1 other identifier: CLEE011O1RU02
• Study Type: observational
• Target: 2,766
• Locations: 1 country
• Sites: 37

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort

  IBCFS at M36, M48, and M60 according to the STEEP 2.0 criteria in a prospective cohort (defined as the time from the start of therapy to one of the listed events: ipsilateral invasive recurrence of breast cancer, locoregional invasive recurrence, distant recurrence, breast cancer-related death, death not associated with breast cancer progression, death from unknown cause, contralateral invasive recurrence of breast cancer) depending on the tumor grade (G2/G3) and the status of lymph node involvement (N0/N1/N2-3)

  Months 36, 48, 60

Secondary Outcomes (7)

• Invasive breast cancer-free survival in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).

  Months 36, 48, 60

• Invasive disease-free survival (IDFS) in prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).

  Months 36, 48, 60

• Recurrence-free survival (RFS) in the prospective and retrospective cohorts depending on the tumor grade (G2/G3) and on the status of lymph nodes involvement (N0/N1/N2-3).

  Months 36, 48, 60

• Number of doses taken relative to the total planned doses of ribociclib %

  Months 36

• Number of participants with AEs/SAEs including those of special interest, in patients receiving ribociclib

  Months 3, 6, 9, 12, 24, 36

Study Arms (2)

Ribociclib+AI

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

Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole

Monotherapy AI

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

Drug: Letrozole; Drug: Anastrozole

Interventions

Anastrozole DRUG

Aromatase inhibitor

Monotherapy AI; Ribociclib+AI

Ribociclib DRUG

CDK4/6 inhibitor

Ribociclib+AI

Letrozole DRUG

Aromatase inhibitor

Monotherapy AI; Ribociclib+AI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with HR+HER2- stage II-III breast cancer receiving adjuvant therapy with ribociclib combined with AI will be include in prospective cohort. Patients with HR+HER2- stage II-III breast cancer receiving adjuvant therapy with AI alone will be included in retrospective cohort.

You may qualify if:

• Patients from the prospective cohort of the study must meet all of the following criteria:
• 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).
• Age ≥18 years at the time of signing the ICF.
• Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
• The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.
• ECOG performance status 0-1
• Patients from the retrospective cohort of the study must meet all of the following criteria:
• Age ≥18 years at the initiation of hormone therapy.
• Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.
• Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020.
• Presence of the necessary information in the source documentation.

You may not qualify if:

• Patients enrolled in the study in prospective cohort should not meet any of the following criteria.
• History of therapy with abemaciclib or palbociclib
• Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form
• Active therapy for other malignant neoplasms
• 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.
• Neoadjuvant or adjuvant therapy with CDK4/6 inhibitors
• A history of another concomitant malignant neoplasm requiring active therapy
• Participation in interventional clinical studies at the time of treatment for breast cancer

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (37)

Novartis Investigative Site

Kaluga, Russia, 248007, Russia

RECRUITING

Novartis Investigative Site

Ryazan, Russia, 390011, Russia

RECRUITING

Novartis Investigative Site

Surgut, Tymen Area, 628402, Russia

RECRUITING

Novartis Investigative Site

Arkhangelsk, 163045, Russia

RECRUITING

Novartis Investigative Site

Barnaul, 656045, Russia

RECRUITING

Novartis Investigative Site

Bryansk, 241028, Russia

RECRUITING

Novartis Investigative Site

Irkutsk, 664035, Russia

RECRUITING

Novartis Investigative Site

Ivanovo, 153040, Russia

RECRUITING

Novartis Investigative Site

Izhevsk, 426009, Russia

RECRUITING

Novartis Investigative Site

Kemerovo, 650036, Russia

RECRUITING

Novartis Investigative Site

Khabarovsk, 680042, Russia

RECRUITING

Novartis Investigative Site

Khanty-Mansiysk, 628012, Russia

RECRUITING

Novartis Investigative Site

Khimky, 121552, Russia

RECRUITING

Novartis Investigative Site

Kirov, 610021, Russia

RECRUITING

Novartis Investigative Site

Krasnoyarsk, 660022, Russia

RECRUITING

Novartis Investigative Site

Moscow, 115304, Russia

RECRUITING

Novartis Investigative Site

Moscow, 115522, Russia

RECRUITING

Novartis Investigative Site

Moscow, 125284, Russia

RECRUITING

Novartis Investigative Site

Moscow, 129110, Russia

RECRUITING

Novartis Investigative Site

Moscow Region Balas, 143900, Russia

RECRUITING

Novartis Investigative Site

Perm, 614066, Russia

RECRUITING

Novartis Investigative Site

Pyatigorsk, 357502, Russia

RECRUITING

Novartis Investigative Site

Rostov-on-Don, 344006, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 194017, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 194291, Russia

RECRUITING

Novartis Investigative Site

Saint Petersburg, 197758, Russia

RECRUITING

Novartis Investigative Site

Saransk, 430032, Russia

RECRUITING

Novartis Investigative Site

Tver', 170008, Russia

RECRUITING

Novartis Investigative Site

Tyumen, 625023, Russia

RECRUITING

Novartis Investigative Site

Ufa, 450054, Russia

RECRUITING

Novartis Investigative Site

Vladikavkaz, 362002, Russia

RECRUITING

Novartis Investigative Site

Vladivostok, 690105, Russia

RECRUITING

Novartis Investigative Site

Volgograd, 400138, Russia

RECRUITING

Novartis Investigative Site

Voronezh, 394036, Russia

RECRUITING

Novartis Investigative Site

Yaroslavl, 150054, Russia

RECRUITING

Novartis Investigative Site

Yekaterinburg, 620036, Russia

RECRUITING

Novartis Investigative Site

Yuzhno-Sakhalinsk, 693010, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

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

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (37)