Clinical trial · Observational
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
NCT06905301CI-TRIAL-00110369IMPULSErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Letrozole | Drug | Letrozole | ALIAS |
| Ribociclib | Drug | Ribociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Using Application
- description
- HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
- interventionNames
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Anastrozole
- label
- Non using Application
- description
- HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
- interventionNames
- Drug: Ribociclib
- Drug: Letrozole
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Number (%) of patients who remain on treatment with ribociclib + AI over the 12 months period
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female and male patients with histologically verified and radically treated stage II-III hormone receptor positive HER2-negative breast cancer; 2. Age ≥ 18 at the time of initiation of ribociclib therapy; 3. Patients who were prescribed ribociclib + AI (±GnRH agonist for premenopausal men and women) not earlier than 28 days before signing the informed consent; 4. It is allowed to start adjuvant hormone therapy with AI (±GnRH agonist) not earlier than 12 months before the start of ribociclib; 5. Provision of written informed consent. Exclusion Criteria: 1. Patients participating in any interventional clinical study at the time of signing the informed consent; 2. Patients receiving active treatment for malignant neoplasms other than BC at the time of enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.