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 range

18 Years

Sex

FEMALE

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

18 Years

Sex

FEMALE

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