N/A
Completed N=559
A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.
Source: ClinicalTrials.gov NCT04671615 ↗Enrolled (actual)
559
Serious AEs
—
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants Categorized According to Type of Index Combination Treatment Regimen — 293; 266 Participants
Summary
The purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in Israel. This study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy.
This study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body.
Patients are followed for around 3.5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Categorized According to Type of Index Combination Treatment Regimen |
293; 266 | — |
| PRIMARY Duration of Index Treatment Per Type of Combination Treatment |
30.5; 12.6 | — |
| PRIMARY Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment |
44; 37; 66; 146; 99; 47 | — |
| PRIMARY Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment |
8; 23; 262; 12; 26; 228 | — |
| PRIMARY Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment |
96; 82 | — |
| PRIMARY Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment |
5.19; 4.57; 4.41; 12.89; 6.08; 4.44 | — |
| PRIMARY Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment |
91.0; 71.1 | — |
| PRIMARY Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment |
76.3; 51.2 | — |
| PRIMARY Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment |
54.7; 26.0 | — |
| PRIMARY Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment |
10; 31 | — |
| PRIMARY Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment |
21; 71 | — |
| PRIMARY Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment |
58; 119 | — |
| PRIMARY Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment |
207; 17; 230; 12 | — |
| PRIMARY Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment |
219; 5; 239; 3 | — |
| PRIMARY Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment |
223; 1; 242; 0 | — |
| PRIMARY Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment |
0.79; 0.92 | — |
| PRIMARY Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment |
34.5; 16.4 | — |
Eligibility Criteria
Inclusion Criteria
- A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry.
- Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting.
- Available data on palbociclib treatment for at least 6 months.
- Continuous healthcare plan enrolment in MHS for at least one year before index date.
Exclusion Criteria
- Patients that initiated HER2 inhibitors.
Data sourced from ClinicalTrials.gov (NCT04671615). 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.