Breast CancerIMPULSENCT06905301
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
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 7 sites in Russia.
Trial summary
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ribociclib, Letrozole and Anastrozole
- How many people
- 240 participants
- Where
- 7 sitesRussia
- Study dates
- 23 Jan 2026to 31 Dec 2029
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HR+ HER2- stage II-III breast cancer who have started treatment with ribociclib + AI (± GnRH agonist for premenopausal men and women) will be enrolled in the study
Who may be able to join
- Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
- Age ≥ 18 at the time of initiation of ribociclib therapy;
- Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
- It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
- Provision of written informed consent.
Who cannot join
- Patients participating in any interventional clinical study at the time of signing the informed consent;
- Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
7 sites in 1 country
Russia7 sites, 7 recruiting
- Recruiting
Novartis Investigative Site
Moscow, 115304
- Recruiting
Novartis Investigative Site
Pskov, Russia, 180000
- 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
Sestroretsk, 197706
- Recruiting
Novartis Investigative Site
Ufa, 450054
About this study
This study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.
- 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 |
|---|---|---|
| Using Application | HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole | |
| Non using Application | HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death)
Measured: 12 months
Secondary outcomes (12)
Number of sessions using the web application per month
To describe the rate of the web application usage in the group of patients who use the web application.
Measured: Month 1 - Month 36
Total duration of sessions (in minutes) per month
To describe the rate of the web application usage in the group of patients who use the web application.
Measured: Month 1 - Month 36
Number of questions to the chatbot per month
To describe the rate of the web application usage in the group of patients who use the web application.
Measured: Month 1 - Month 36
Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)
Evaluation of patient satisfaction with the application on a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Measured: Month 1, 3, 6, 12, 24, 36
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS, where 0 is for completely dissatisfied, 10 is for completely satisfied in M1, M3, M6, M12, M24, M36
Measured: Month 1, 3, 6, 12, 24, 36
Number of patients in each response category according to the questionnaire on quality of life
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) in M1, M3, M6, M12, M24, M36 in the groups using and not using the web application
Measured: Month 1, 3, 6, 12, 24, 36
VAS score according to the questionnaire on quality of life
VAS score according to the questionnaire (VAS 0-100, where 0 is the worst health state and 100 is the best health state) at M1, M3, M6, M12, M24, and M36 in both app user and non-app user groups
Measured: Month 1, 3, 6, 12, 24, 36
Assessment of patient satisfaction with treatment
Assessment of patient satisfaction with treatment (VAS 0-10, where 0 is completely dissatisfied, and 10 is completely satisfied) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Measured: Month 3, 6, 12, 24, 36
Dose intensity
Dose intensity (% of missed doses as assessed by the patient, except for therapy suspension due to AE) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Measured: Month 3, 6, 12, 24, 36
Number of patients with adverse events (AE)
The percentage (%) of patients with AE (cumulative and depending on the severity) at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Measured: Month 3, 6, 12, 24, 36
Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE
The percentage (%) of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE at M3, M6, M12, M24, and M36 in both app user and non-app user groups
Measured: Month 3, 6, 12, 24, 36
Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups
Proportion (%) of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start23 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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
- 240 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
- NCT06905301
- Sponsor's protocol ID
- CLEE011O1RU01
- Acronym
- IMPULSE
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06905301
- Acronym / sponsor ID
- IMPULSE / CLEE011O1RU01
- Conditions
- Breast Cancer
- Keywords
- Breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 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 study is designed to evaluate the effect of using the application on the adherence of patients with luminal HER2- breast cancer (BC) stage II-III to adjuvant therapy with ribociclib in combination with an aromatase inhibitor (AI). The purpose of the app is to increase adherence to treatment by informing patients about the risks of relapse and adverse event prevention and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using Application | – | Drug: Ribociclib, Drug: Letrozole, Drug: AnastrozoleHR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application |
| Non using Application | – | Drug: Ribociclib, Drug: Letrozole, Drug: AnastrozoleHR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HR+ HER2- stage II-III breast cancer who have started treatment with ribociclib + AI (± GnRH agonist for premenopausal men and women) will be enrolled in the study
Key inclusion criteria (5 listed)
- Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer;
- Age ≥ 18 at the time of initiation of ribociclib therapy;
- Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent;
- It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib;
- Provision of written informed consent.
Key exclusion criteria (2 listed)
- Patients participating in any interventional clinical study at the time of signing the informed consent;
- Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
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 | Non using Application, Using Application |
| LetrozoleAromatase inhibitor | Drug | Non using Application, Using Application |
| AnastrozoleAromatase inhibitor | Drug | Non using Application, Using Application |
Primary outcome
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
Time frame: 12 months
The difference between the two groups (App and non-App) in number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (excluding patients who discontinued treatment due to AE, disease relapse, or death)
12 secondary outcomes
Number of sessions using the web application per month
Time frame: Month 1 - Month 36
Total duration of sessions (in minutes) per month
Time frame: Month 1 - Month 36
Number of questions to the chatbot per month
Time frame: Month 1 - Month 36
Evaluation of patient satisfaction with the application on a 0-10 visual analog scale (VAS)
Time frame: Month 1, 3, 6, 12, 24, 36
Evaluation of oncologist satisfaction with the application according to a 0-10 VAS
Time frame: Month 1, 3, 6, 12, 24, 36
Number of patients in each response category according to the questionnaire on quality of life
Time frame: Month 1, 3, 6, 12, 24, 36
VAS score according to the questionnaire on quality of life
Time frame: Month 1, 3, 6, 12, 24, 36
Assessment of patient satisfaction with treatment
Time frame: Month 3, 6, 12, 24, 36
Dose intensity
Time frame: Month 3, 6, 12, 24, 36
Number of patients with adverse events (AE)
Time frame: Month 3, 6, 12, 24, 36
Number of patients with dose reduction and/or discontinuation of ribociclib therapy due to progression, death for breast cancer, death from another cause, other AE
Time frame: Month 3, 6, 12, 24, 36
Number of patients by age, education, occupation, TNM (tumor, nodus, metastasis) stage, tumor grade (G), Ki67 level in both app user and non-app user groups
Time frame: Baseline
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 5 May 2026.
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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
7 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 7 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 5 inclusion and 2 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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period (time frame: 12 months). 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 5 May 2026.