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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study included HR+/HER2- aBC patients who received ribociclib in combination with ET in India.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Progression-free Survival (rwPFS) for the Entire Patient Group	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.	Up to approximately 42 months
rwPFS by Line of Therapy for the Entire Patient Group	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.	Up to approximately 42 months
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group	Clinical response categories included complete response, any response (other than complete response), no response, and any progression.	Up to approximately 42 months
Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group	Clinical response categories included complete response, any response (other than complete response), no response, and any progression.	Up to approximately 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rwPFS for Patients With at Least 6 Months of Follow-up	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.	Up to approximately 42 months
rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up	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.	Up to approximately 42 months
Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up	Clinical response categories included complete response, any response (other than complete response), no response, and any progression.	Up to approximately 42 months
Number of Patients With Adverse Events		Up to approximately 42 months
Number of Adverse Events		Up to approximately 42 months
Number of Adverse Events by Severity		Up to approximately 42 months
Number of Patients who Discontinued Treatment by Reason for Discontinuation		Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Discontinuation		Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Interruptions		Up to approximately 42 months
Number of Patients by Adverse Event That Led to Dose Reduction		Up to approximately 42 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2022
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: January 16, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ribociclib; Metastasis; Endocrine therapy; Progression-free survival
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CLEE011AIN01