Clinical trial · Observational
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
NCT05452798CI-TRIAL-00074607completedResults postedClinicalTrials.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 objective is to retrospectively describe and assess clinical and demographical characteristics, treatment patterns in a real-world (RW) setting of patients with HR+/HER2- (hormone receptor positive/human epidermal growth factor receptor 2 negative) locally advanced or metastatic breast cancer receiving palbociclib in combination treatment
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
- timeFrame
- From index date until the first documentation of disease progression or death or censoring date of 07-Mar-2022 (maximum up to 5.2 years)
- description
- PFS was defined as the time from the index date to progression or death, whichever occurred first. Progression of disease was based on scans and blood testing results. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Index date was date of relapse or stage IV disease. Stage IV disease means that the cancer has spread to distant parts of the body. Kaplan-Meier method was used for analysis.
- measure
- Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI)
- timeFrame
- From start date of palbociclib treatment until stop date of palbociclib treatment (maximum up to 5.2 years)
- description
- ToT was defined as date of palbociclib treatment start to date of treatment stop with palbociclib.
Secondary outcomes (12)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with breast cancer (International Statistical Classification of Diseases and Related Health Problems, 10th Revision \[ICD-10\]: ICD-10 code for patients with breast cancer \[DC50\]) * A diagnosis of HR+/HER2- locally advanced or metastatic breast cancer * Initiated treatment with palbociclib as either 1st or 2nd line treatment between 01 January 2017 and 31 December 2020 * Inclusion date: Date of relapse/stage IV disease/progression leading to initiation of palbociclib+AI/progression leading to initiation of palbociclib+fulvestrant Exclusion Criteria: * There are no exclusion criteria for this study
References
Publications (0)
Data not yet available
No reference posted for this study.