A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients

NCT07760714 | Completed

• 1 other identifier: CLEE011AUS70
• Study Type: observational
• Target: 945
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.

Conditions

Breast Cancer

Keywords

Ribociclib; CDK4/6 inhibitor; Metastatic breast cancer; HR+/HER2-; Real-world evidence; Treatment patterns; Dose modification; Tolerability; Older adults; African American

Outcome Measures

Primary Outcomes (10)

• Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.

  Baseline

• Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Baseline

• Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Baseline

• Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Status Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older,

  ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).

  Baseline

• Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Baseline

• Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Up to approximately 6 years, 10 months

• Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Dose modifications defined as a dose being held, increased, or decreased.

  Up to approximately 6 years, 10 months

• Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Dose modifications defined as a dose being held, increased, or decreased.

  Up to approximately 6 years, 10 months

• Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Up to approximately 6 years, 10 months

• Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older

  Up to approximately 6 years, 10 months

Secondary Outcomes (10)

• Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients

  Baseline

• Age at 1L Ribociclib Initiation Among Black/African American Patients

  Baseline

• BMI at 1L Ribociclib Initiation Among Black/African American Patients

  Baseline

• Number of Patients by ECOG Performance Status Among Black/African American Patients

  Baseline

• Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients

  Baseline

Study Arms (3)

Adults Aged 65 and Older

HR+/HER2- mBC cancer patients aged 65 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.

Adults Aged 75 and Older

HR+/HER2- mBC cancer patients aged 75 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.

Black or African American Adults

HR+/HER2- mBC cancer patients aged 65 years or older who self-identify as Black/African American and initiated 1L ribociclib plus ET on or after January 01, 2018.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HR+/HER2- recurrent or mBC cancer patients aged 65 years or older, and who self-identify as African American, and initiated 1L ribociclib plus ET on or after January 01, 2018.

You may qualify if:

• Included in Flatiron's mBC Enhanced Data Model (EDM):
• Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification \[ICD-9-CM\] 174.x or 175.x or ICD, 10th revision, clinical modification \[ICD-10-CM\] C50x)
• At least two documented clinical visits, on different days, occurring on or after January 1, 2011
• Included in probabilistic sample of patients queued for review via abstraction
• Had pathology consistent with breast cancer
• Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease
• Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy \[ET\]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations
• Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib
• Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024

You may not qualify if:

• Use of any CDK4/6 inhibitor therapy in combination with tamoxifen
• Use of any CDK4/6 inhibitor in the pre-metastatic setting

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: August 7, 2026
• First Posted: August 12, 2026
• Study Start: February 26, 2025
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)