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Completed

NCT Number: NCT07363434

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Real-world Progression-free Survival (rwPFS) for the Entire Patient Group

    Time frame: Up to approximately 42 months

    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.

  2. rwPFS by Line of Therapy for the Entire Patient Group

    Time frame: Up to approximately 42 months

    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.

  3. Duration of Clinical Response by Type of Clinical Response and Line of Therapy for the Entire Patient Group

    Time frame: Up to approximately 42 months

    Clinical response categories included complete response, any response (other than complete response), no response, and any progression.

  4. Number of Patients by Type of Clinical Response and Line of Therapy for the Entire Patient Group

    Time frame: Up to approximately 42 months

    Clinical response categories included complete response, any response (other than complete response), no response, and any progression.

Secondary outcomes

  1. rwPFS for Patients With at Least 6 Months of Follow-up

    Time frame: Up to approximately 42 months

    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.

  2. rwPFS by Line of Therapy for Patients With at Least 6 Months of Follow-up

    Time frame: Up to approximately 42 months

    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.

  3. Duration of Clinical Response by Type of Clinical Response and Line of Therapy for Patients With at Least 6 Months of Follow-up

    Time frame: Up to approximately 42 months

    Clinical response categories included complete response, any response (other than complete response), no response, and any progression.

  4. Number of Patients With Adverse Events

    Time frame: Up to approximately 42 months

  5. Number of Adverse Events

    Time frame: Up to approximately 42 months

  6. Number of Adverse Events by Severity

    Time frame: Up to approximately 42 months

  7. Number of Patients who Discontinued Treatment by Reason for Discontinuation

    Time frame: Up to approximately 42 months

  8. Number of Patients by Adverse Event That Led to Dose Discontinuation

    Time frame: Up to approximately 42 months

  9. Number of Patients by Adverse Event That Led to Dose Interruptions

    Time frame: Up to approximately 42 months

  10. Number of Patients by Adverse Event That Led to Dose Reduction

    Time frame: Up to approximately 42 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: RESONATE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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