N/A
Completed N=1,054
A Retrospective Non-interventional Study of Breast Cancer Patients Diagnosed With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib in Denmark
Source: ClinicalTrials.gov NCT05452798 ↗Enrolled (actual)
1,054
Serious AEs
—
Results posted
Mar 2024
Primary outcomePrimary: Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) — 27.4 Months
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) |
27.4 | — |
| PRIMARY Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Aromatase Inhibitor (AI) |
18.5 | — |
| SECONDARY Overall Survival (OS) in Participants Who Received Palbociclib in Combination With AI |
54.2 | — |
| SECONDARY Progression-Free Survival (PFS) for Participants Who Received Palbociclib in Combination With Fulvestrant |
14.9 | — |
| SECONDARY Time on Treatment (ToT) for Participants Who Received Palbociclib in Combination With Fulvestrant |
11.2 | — |
| SECONDARY OS in Participants Who Received Palbociclib in Combination With Fulvestrant |
32.9 | — |
| SECONDARY Number of Participants According to First Subsequent Post-Palbociclib Treatment Upon Progression |
350; 315; 2 | — |
| SECONDARY Number of Participants According to Type of Metastases |
105; 405; 530; 14 | — |
| SECONDARY Number of Participants According to Number of Metastases |
14; 375; 303; 362 | — |
| SECONDARY Number of Participants According to Location of Metastases |
80; 790; 417; 268; 41; 480 | — |
| SECONDARY Number of Participants Who Underwent Surgery |
96 | — |
| SECONDARY Number of Participants According to Type of Adjuvant Treatment |
552; 202; 194; 176; 122 | — |
| SECONDARY Number of Participants With De Novo and Recurrent Metastatic Breast Cancer |
784; 270 | — |
| SECONDARY Median Time From Initial Breast Cancer Diagnosis to Relapse |
5.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05452798). 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.