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 (IMPULSE)

Novartis

Status: Enrolling

Conditions: Breast Cancer

Treatments: Drug: Letrozole; Drug: Ribociclib; Drug: Anastrozole

Study type: Observational

Funder types: Industry

Identifiers

NCT06905301

CLEE011O1RU01

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 2 patient groups

Using Application

Description:

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that use the web application

Treatment:

Drug: Anastrozole

Drug: Ribociclib

Drug: Letrozole

Non using Application

Description:

HR + HER2- BC patients receiving adjuvant ribociclib + AI therapy in routine clinical practice that do not use the web application

Treatment:

Drug: Anastrozole

Drug: Ribociclib

Drug: Letrozole