N/A
Completed N=652
Ibrance Real World Insights
Malignant Neoplasm of Breast
Source: ClinicalTrials.gov NCT03159195 ↗
Enrolled (actual)
652
Serious AEs
—
Results posted
Sep 2021
Primary outcomePrimary: Percentage of Participants With Progression Free Survival (PFS) at Month 12 — 84.1; 79.8 Percentage of participants
Summary
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression Free Survival (PFS) at Month 12 |
84.1; 79.8 | — |
| PRIMARY Percentage of Participants With Progression Free Survival at Month 24 |
64.3 | — |
| PRIMARY Percentage of Participants With Objective Response Rate (ORR) |
79.5; 74.0 | — |
| PRIMARY Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation |
95.1; 87.9 | — |
| PRIMARY Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation |
90.1 | — |
Eligibility Criteria
Physician inclusion criteria
- Oncologist or gynecologist
- Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.
- Agrees to participate in the study and complete the eCRFs within the data collection period.
Patient inclusion criteria
- Female
- ≥18 years old.
- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
- Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).
- No prior or current enrolment in an interventional clinical trial for ABC/MBC.
- Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).
- Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).
- Inoperable or recurrent breast cancer (Japan only)
Exclusion criteria
Physician exclusion criteria
- Qualified less than 2 years ago or more than 35 years ago
- Participated in observational research for ABC/MBC in the last 3 months
- Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).
Data sourced from ClinicalTrials.gov (NCT03159195). 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.