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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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Novartis Investigative Site
RECRUITING
Moscow
Novartis Investigative Site
RECRUITING
Pskov
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Saint Petersburg
Novartis Investigative Site
RECRUITING
Ufa
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2026-01-23
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 240
Treatments
Using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application
Non using Application
HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov