Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Ribociclib Group
- description
- Indian women with a confirmed diagnosis of HR+, HER2- aBC who were treated with ribociclib in combination with ET.
Primary outcomes (4)
- measure
- Real-world Progression-free Survival (rwPFS) for the Entire Patient Group
- timeFrame
- Up to approximately 42 months
- description
- rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
- measure
- rwPFS by Line of Therapy for the Entire Patient Group
- timeFrame
- Up to approximately 42 months
- description
- rwPFS was defined as the time from the start of ribociclib treatment in combination with ET to disease progression, as assessed by the treating physician, or death due to any cause.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available