CompletedNot Applicable

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

United States480 participantsStarted 2024-10-08

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * 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. Exclusion criteria: * 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.

What they're measuring

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

Timeframe: Baseline

Age at 1L Ribociclib Treatment Initiation

Timeframe: Baseline

Among 1L Ribociclib Patients, Age at mBC Diagnosis

Timeframe: Baseline

Among 1L Ribociclib Patients, Age at Initial BC Diagnosis

Timeframe: Baseline

Interval Between mBC Diagnosis and 1L Ribociclib Initiation

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Follow-up Time From 1L Ribociclib Treatment Initiation

Timeframe: Up to approximately 7 years and 6 months

Trial details

NCT IDNCT07512063

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-03-17

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Baseline

Age at 1L Ribociclib Treatment Initiation

Timeframe: Baseline

Among 1L Ribociclib Patients, Age at mBC Diagnosis

Timeframe: Baseline

Among 1L Ribociclib Patients, Age at Initial BC Diagnosis

Timeframe: Baseline

Interval Between mBC Diagnosis and 1L Ribociclib Initiation

Timeframe: Baseline

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

Timeframe: Baseline

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

Timeframe: Baseline

Follow-up Time From 1L Ribociclib Treatment Initiation

Timeframe: Up to approximately 7 years and 6 months