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NCT06905301 | NOT YET RECRUITING | Breast Cancer

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
Sponsor:

Novartis Pharmaceuticals

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.

Condition or disease

Breast Cancer

Intervention/treatment

Ribociclib

Letrozole

Anastrozole

Study Type : OBSERVATIONAL
Estimated Enrollment : 240 participants
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
Actual Study Start Date : 2025-07-31
Estimated Primary Completion Date : 2029-07-01
Estimated Study Completion Date : 2029-07-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT06905301

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