NCT06905301 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
| NCT ID | NCT06905301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2026-01-23 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2026-01-23 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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). 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06905301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06905301 currently recruiting?
Yes, NCT06905301 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06905301 trial being conducted?
This trial is being conducted at Pskov, Russia, Moscow, Russia, Saint Petersburg, Russia, Saint Petersburg, Russia and 3 additional locations.
Who is sponsoring the NCT06905301 clinical trial?
NCT06905301 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 240 participants.
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