NCT07760714Completed
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
Real-World, Retrospective Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer, With a Focus on Patients 65 Years and Older, and Patients Who Self-identify as African American
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 945 (actual)
- First submitted
- 7 Aug 2026
- Start date
- 26 Feb 2025
- Primary completion date
- 29 Aug 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07760714
What you commit to
- Study type: Observational
- Participants enrolled: 945
- From 26 Feb 2025 to the primary completion date, 29 Aug 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 CDK4/6 inhibitor therapy in combination with tamoxifen
- Use of any CDK4/6 inhibitor in the pre-metastatic setting
Who the study is looking for
- Included in Flatiron's mBC Enhanced Data Model (EDM):
- Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification \[ICD-9-CM\] 174.x or 175.x or ICD, 10th revision, clinical modification \[ICD-10-CM\] C50x)
- At least two documented clinical visits, on different days, occurring on or after January 1, 2011
- Included in probabilistic sample of patients queued for review via abstraction
- Had pathology consistent with breast cancer
- Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease
- Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy \[ET\]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations
- Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib
- Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024
Age in the registry: 18 years to 120 years · Sex: All · 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.