NCT07512063Completed
A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors
Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 480 (actual)
- First submitted
- 12 Mar 2026
- Start date
- 8 Oct 2024
- Primary completion date
- 17 Mar 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07512063
What you commit to
- Study type: Observational
- Participants enrolled: 480
- From 8 Oct 2024 to the primary completion date, 17 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- Evidence of participation in a clinical trial at any time during the study observation period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.