Clinical trial · Observational
Patterns of Prescribing and Monitoring of Palbociclib
NCT03285568CI-TRIAL-00065219completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Estrogen Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Palbociclib
- description
- women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib
- interventionNames
- Drug: Palbociclib
Primary outcomes (1)
- measure
- Palbociclib dose according to the package insert recommendations.
- timeFrame
- 22 months
- description
- Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.
Secondary outcomes (5)
- measure
- Dose adjustment for hematologic toxicities
- timeFrame
- 22 months
- description
- Number of patients who required dose adjustment for hematologic toxicities while on the study.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * women at least 18 years old * ER+, HER2- advanced breast cancer * receiving palbociclib Exclusion Criteria: * brain metastases * on palbociclib clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.