N/A
Completed N=1,170
Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan
Source: ClinicalTrials.gov NCT05153187 ↗Enrolled (actual)
1,170
Serious AEs
—
Results posted
Apr 2026
Primary outcomePrimary: Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation — 17.4; 12.9; 28.4; 29.7 Percentage of participants
Summary
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation |
17.4; 12.9; 28.4; 29.7; 8.3; 3.3 | — |
| PRIMARY Percentage of Participants According to Number of Blood Tests at 5 to 8 Weeks From Palbociclib Treatment Initiation |
23.6; 25.5; 38.5; 9.3; 2.1; 1.0 | — |
| PRIMARY Percentage of Participants According to Number of Blood Tests at 9 to 12 Weeks From Palbociclib Treatment Initiation |
27.6; 32.6; 31.1; 6.1; 1.4; 1.3 | — |
| PRIMARY Percentage of Participants According to Number of Blood Tests at 13 to 16 Weeks From Palbociclib Treatment Initiation |
31.8; 37.9; 22.1; 5.7; 1.4; 1.0 | — |
| PRIMARY Percentage of Participants According to Number of Blood Tests at 17 to 20 Weeks From Palbociclib Treatment Initiation |
34.0; 39.2; 21.1; 4.2; 0.7; 0.8 | — |
| PRIMARY Time to Treatment Failure of Palbociclib |
9.8 | — |
| SECONDARY Mean Palbociclib Daily Dose |
135.7 | — |
| SECONDARY Number of Participants According to Regimen of First Subsequent Therapy After End of Palbociclib |
39; 17; 6; 4; 4; 3 | — |
| SECONDARY Time to Treatment Failure of Subsequent Therapy After End of Palbociclib |
7.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of breast cancer based on International statistical classification of diseases and related health problems 10th revision (International Statistical Classification of Diseases and Related Health Problems [ICD-10]) (C50.xx)
- Received at least one prescription of endocrine therapy drugs
- Diagnosis of secondary malignant neoplasm based on ICD-10 (C77.x, C78.x, C79.x )
Exclusion Criteria
-Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)
Data sourced from ClinicalTrials.gov (NCT05153187). 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.