A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib (RESONATE)

Novartis

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07363434

CLEE011AIN01

Details and patient eligibility

About

The aim of this study was to assess the effectiveness, safety, and tolerability of ribociclib in Indian women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (aBC).

This study used secondary data sources, i.e., paper-based records; electronic medical records (EMRs); and other sources, such as radiology reports, pathology reports, and examination/clinician notes related to aBC, from clinics/hospitals across 18 sites in India. Aggregated data of anonymized patients treated with ribociclib plus endocrine therapy (ET) by the approved indication between June 2018 and December 2021 were collected and analyzed.

Enrollment: 335 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ≥18 years old diagnosed with HR+ and HER2- aBC who received at least one dose of ribociclib in combination with ET following the approved indication, with at least one follow-up visit after diagnosis or death due to any cause.

Exclusion criteria

• Patients with prior/current enrollment in an interventional clinical trial for aBC/metastatic breast cancer and those who had received another cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor in any setting.

Trial design

335 participants in 1 patient group

Ribociclib Group

Description:

Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET.