Clinical Trials Directory

Trials / Completed

CompletedNCT07363434

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

RESONATE Study: Real-world Outcomes With Ribociclib in Indian Patients With HR+, HER2- Advanced Breast Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
335 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2022-12-21
Primary completion
2024-07-26
Completion
2024-07-26
First posted
2026-01-23
Last updated
2026-01-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07363434. Inclusion in this directory is not an endorsement.