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

NCT07363434 | Completed

• 1 other identifier: CLEE011AIN01
• Study Type: observational
• Target: 335
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Ribociclib; Endocrine therapy; Metastasis; Progression-free survival

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

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

  Up to approximately 42 months

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

  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

  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

Study Arms (1)

Ribociclib Group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 23, 2026
• Study Start: December 21, 2022
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)