A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors

NCT07512063 | Completed

• 1 other identifier: CLEE011AUS74
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.

Conditions

Breast Cancer

Keywords

Ribociclib; CDK4/6i; Metastatic breast cancer

Outcome Measures

Primary Outcomes (28)

• Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category

  Demographics included: * Age group * Sex * Race * Ethnicity * Geographical region * Payer type * Year of 1L treatment initiation * De novo or recurrent mBC

  Baseline

• Age at 1L Ribociclib Treatment Initiation

  Baseline

• Among 1L Ribociclib Patients, Age at mBC Diagnosis

  Baseline

• Among 1L Ribociclib Patients, Age at Initial BC Diagnosis

  Baseline

• Interval Between mBC Diagnosis and 1L Ribociclib Initiation

  Baseline

• Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category

  Clinical characteristics included: * Menopausal status * Eastern Cooperative Oncology Group (ECOG) performance status * Stage at initial breast cancer (BC) diagnosis * Comorbidities * QT prolongation diagnosis (yes/no) * Sites of metastasis

  Baseline

• Among 1L Ribociclib Patients, Body Mass Index (BMI)

  Baseline

• Follow-up Time From 1L Ribociclib Treatment Initiation

  Up to approximately 7 years and 6 months

• Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline

  Baseline

• Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study

  Up to approximately 7 years and 6 months

• Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up

  Up to approximately 7 years and 6 months

• Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received

  Baseline

• Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline

  Baseline

• Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study

  Up to approximately 7 years and 6 months

• Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count

  Baseline

• Among 1L Ribociclib Patients, Hemoglobin Level

  Baseline

• Among 1L Ribociclib Patients, Hematocrit Level

  Baseline

• Among 1L Ribociclib Patients, White Blood Cell Count

  Baseline

• Among 1L Ribociclib Patients, Platelet Count

  Baseline

• Number and Percentage of 1L Ribociclib Patients With Neutropenia

  Baseline

• Among 1L Ribociclib Patients, Serum Creatinine Level

  Baseline

• Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level

  Baseline

• Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level

  Baseline

• Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level

  Baseline

• Among 1L Ribociclib Patients, Bilirubin Level

  Baseline

• Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment

  Baseline

• Interval Between Treatment Initiation and Ribociclib Initiation

  Baseline

• Number and Percentage of Patients by Type of Treatment Received per Line of Treatment

  Up to approximately 7 years and 6 months

Secondary Outcomes (7)

• Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment

  Up to approximately 7 years and 6 months

• Among 1L Ribociclib Patients, Number of Total Dose Adjustments

  Up to approximately 7 years and 6 months

• Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib

  Baseline

• Relative Dose Intensity (RDI) of Ribociclib

  Up to approximately 7 years and 6 months

• Ribociclib Dose at First Dose Adjustment

  Up to approximately 7 years and 6 months

Study Arms (1)

CDK4/6i Cohort

Adult HR+/HER2- mBC patients treated with 1L ribociclib, palbociclib, or abemaciclib.

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

HR+/HER2- mBC patients who received 1L CDK4/6i treatment and have a medical record in the real-world evidence database.

You may qualify if:

• A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification \[ICD-10-CM\] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date.
• Patients with HR+/HER2- status.
• Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC.
• Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date.

You may not qualify if:

• Use of any prior CDK4/6i before the index date.
• Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data.
• Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index.
• Evidence of participation in a clinical trial at any time during the study observation period.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Link to study results

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: March 12, 2026
• First Posted: April 6, 2026
• Study Start: October 8, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)