Breast CancerELEGANCENCT06930859
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
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 42 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib, Letrozole and Anastrozole
- How many people
- 2,766 participants
- Where
- 42 sitesRussia
- Study dates
- 3 Dec 2025to 31 Dec 2032
- 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- 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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
- Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.
Trial locations and contacts
42 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
42 sites in 1 country
Russia42 sites, 42 recruiting
- Recruiting
Novartis Investigative Site
Arkhangelsk, 163045
- Recruiting
Novartis Investigative Site
Barnaul, 656045
- Recruiting
Novartis Investigative Site
Bryansk, 241028
- Recruiting
Novartis Investigative Site
Irkutsk, 664035
- Recruiting
Novartis Investigative Site
Ivanovo, 153040
- Recruiting
Novartis Investigative Site
Izhevsk, 426009
- Recruiting
Novartis Investigative Site
Kaluga, Russia, 248007
- Recruiting
Novartis Investigative Site
Kemerovo, 650036
- Recruiting
Novartis Investigative Site
Khabarovsk, 680042
- Recruiting
Novartis Investigative Site
Khanty-Mansiysk, 628012
- Recruiting
Novartis Investigative Site
Khimky, 121552
- Recruiting
Novartis Investigative Site
Kirov, 610021
- Recruiting
Novartis Investigative Site
Krasnoyarsk, 660022
- Recruiting
Novartis Investigative Site
Moscow, 115304
- Recruiting
Novartis Investigative Site
Moscow, 115522
- Recruiting
Novartis Investigative Site
Moscow, 125284
- Recruiting
Novartis Investigative Site
Moscow, 129110
- Recruiting
Novartis Investigative Site
Moscow Region Balas, 143900
- Recruiting
Novartis Investigative Site
Perm, 614066
- Recruiting
Novartis Investigative Site
Pskov, Russia, 180000
- Recruiting
Novartis Investigative Site
Pyatigorsk, 357502
- Recruiting
Novartis Investigative Site
Rostov-on-Don, 344006
- Recruiting
Novartis Investigative Site
Ryazan, Russia, 390011
- Recruiting
Novartis Investigative Site
Saint Petersburg, Russia, 197758
- Recruiting
Novartis Investigative Site
Saint Petersburg, 194017
- Recruiting
Novartis Investigative Site
Saint Petersburg, 194291
- Recruiting
Novartis Investigative Site
Saint Petersburg, 197758
- Recruiting
Novartis Investigative Site
Saransk, 430032
- Recruiting
Novartis Investigative Site
Saratov, 410053
- Recruiting
Novartis Investigative Site
Sestroretsk, 197706
- Recruiting
Novartis Investigative Site
Sochi, Russian Federation, 354057
- Recruiting
Novartis Investigative Site
Surgut, Tymen Area, 628402
- Recruiting
Novartis Investigative Site
Tver', 170008
- Recruiting
Novartis Investigative Site
Tyumen, 625023
- Recruiting
Novartis Investigative Site
Ufa, 450054
- Recruiting
Novartis Investigative Site
Vladikavkaz, 362002
- Recruiting
Novartis Investigative Site
Vladivostok, 690105
- Recruiting
Novartis Investigative Site
Volgograd, 400138
- Recruiting
Novartis Investigative Site
Voronezh, 394036
- Recruiting
Novartis Investigative Site
Yaroslavl, 150054
- Recruiting
Novartis Investigative Site
Yekaterinburg, 620036
- Recruiting
Novartis Investigative Site
Yuzhno-Sakhalinsk, 693010
About this study
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
- Being tested
- Ribociclib, Letrozole, Anastrozole
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
CDK4/6 inhibitor
LetrozoleDrug
Aromatase inhibitor
AnastrozoleDrug
Aromatase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib+AI | Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor) Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole | |
| Monotherapy AI | Patients with HR+ HER2- stage II-III breast cancer receiving adjuvant AI (aromatase inhibitor) monotherapy Receives: Drug: Letrozole; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
IBCFS at M36, M48, and M60 according to the STEEP 2.0 criteria in prospective and retrospective cohorts (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 on the status of lymph nodes involvement (N0/N1/N2-3).
Measured: 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).
IDFS is defined as the time from surgery until first occurrence of invasive breast cancer recurrence, distant recurrence, or death from any cause
Measured: 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).
Recurrence-free survival is the length of time after the treatment of the cancer ends that the patient survives without cancer symptoms.
Measured: Months 36, 48, 60
Number of doses taken relative to the total planned doses of ribociclib %
To evaluate the dose intensity of ribociclib.
Measured: Months 36
Number of participants with AEs/SAEs including those of special interest, in patients receiving ribociclib
The frequency of AE/SAE of varying severity, including those of special interest (neutropenia, elevated ALT/AST, prolonged QT interval), expressed as a percentage of the total study population receiving ribociclib
Measured: Months 3, 6, 9, 12, 24, 36
Number of patients who discontinued ribociclib for any reason, due to any AE, and due to AEs of special interest
The frequency of ribociclib discontinuation for any reason, due to any AE, and due to AEs of special interest (neutropenia, elevated ALT/AST, prolonged QT interval), expressed as a percentage of the total study population receiving ribociclib
Measured: Months 3, 6, 9, 12, 24, 36
Patients' quality of life evaluated through a questionnaire
The number (%) of patients in each response category (no problems, mild problems, moderate problems, severe problems, and extremely severe problems) according to the questionnaire scale (mobility, self-care, normal activities, pain/discomfort, anxiety/depression). The scale on 5 particular symptoms from 1 (no difficulties) to 5 (severe limitations).
Measured: Months 3, 6, 9, 12, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start3 Dec 2025
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 2,766 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930859
- Sponsor's protocol ID
- CLEE011O1RU02
- Acronym
- ELEGANCE
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06930859
- Acronym / sponsor ID
- ELEGANCE / CLEE011O1RU02
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,766 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribociclib+AI | – | Drug: Ribociclib, Drug: Letrozole, Drug: AnastrozolePatients with HR+ HER2- stage II-III breast cancer receiving adjuvant ribociclib plus AI (aromatase inhibitor) |
| Monotherapy AI | – | Drug: Letrozole, Drug: AnastrozolePatients with HR+ HER2- stage II-III breast cancer receiving adjuvant AI (aromatase inhibitor) monotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibociclibCDK4/6 inhibitor | Drug | Ribociclib+AI |
| LetrozoleAromatase inhibitor | Drug | Monotherapy AI, Ribociclib+AI |
| AnastrozoleAromatase inhibitor | Drug | Monotherapy AI, Ribociclib+AI |
Primary outcome
Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort
Time frame: Months 36, 48, 60
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)
7 secondary outcomes
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).
Time frame: 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).
Time frame: 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).
Time frame: Months 36, 48, 60
Number of doses taken relative to the total planned doses of ribociclib %
Time frame: Months 36
Number of participants with AEs/SAEs including those of special interest, in patients receiving ribociclib
Time frame: Months 3, 6, 9, 12, 24, 36
Number of patients who discontinued ribociclib for any reason, due to any AE, and due to AEs of special interest
Time frame: Months 3, 6, 9, 12, 24, 36
Patients' quality of life evaluated through a questionnaire
Time frame: Months 3, 6, 9, 12, 24, 36, 48, 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 42 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
Contact Novartis Pharmaceuticals (+41613241111, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive breast cancer-free survival (IBCFS) according to the Standardized Definitions for Efficacy End Points (STEEP) criteria in a prospective cohort (time frame: Months 36, 48, 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2026.