A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors
Completed
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07512063
- Run by
- Novartis Pharmaceuticals
- People needed
- 480
- Starts
- 2024-10-08
- Expected to finish
- 2025-03-17
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- Novartis — East Hanover, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.