N/A
Completed N=317
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
Source: ClinicalTrials.gov NCT04460911 ↗Enrolled (actual)
317
Serious AEs
—
Results posted
Jan 2024
Primary outcomePrimary: Time to Chemotherapy — NA Weeks
Summary
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Chemotherapy |
NA | — |
| PRIMARY Number of Participants According to Reasons for Treatment Discontinuation |
133; 20; 1; 15; 44; 17 | — |
| PRIMARY Real-World Duration of Treatment (rwDOT) |
15.8 | — |
| PRIMARY Time to Next Treatment (TTNT) From Index Treatment |
16.8 | — |
| PRIMARY Percentage of Participants With Provider Documented Disease Progression |
42.0 | — |
| PRIMARY Real-World Time to Tumor Progression (rwTTP) |
26.7 | — |
| PRIMARY Real-World Progression-Free Survival (rwPFS) |
19.6 | — |
| PRIMARY Overall Survival (OS) |
44.1 | — |
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of HR+/HER2- mBC
- Initiated palbociclib + fulvestrant as first-line therapy in the metastatic setting and had at least 2 visits following the index date
- Received care at a US oncology site(s) utilizing the full EHR at time of treatment and data are available for research purposes
Exclusion Criteria
- Enrollment in an interventional clinical trial during the study period
- Evidence of prior treatment with CDK4/6 inhibitors in the metastatic setting
- Receipt of treatment indicated for another primary cancer during the study period or history of another primary cancer documented within the US Oncology EHR.
Data sourced from ClinicalTrials.gov (NCT04460911). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.