A Real-world Study of Indian Patients With Advanced Breast Cancer Treated With Ribociclib
Completed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07363434
- Run by
- Novartis Pharmaceuticals
- People needed
- 335
- Starts
- 2022-12-21
- Expected to finish
- 2024-07-26
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.