Demographics, Characteristics, Treatment Patterns and Clinical Outcomes of Palbociclib Treated Patients in Israel
Study Details
Study Description
Brief Summary
This non-interventional study aims to describe patient demographics, clinical characteristics, clinical outcomes and treatment patterns of adult breast cancer patients who have initiated palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy. This is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with metastatic, HR+/HER2- breast cancer. Patients who initiated first or subsequent lines of treatment with palbociclib |
Drug: palbociclib
As provided in real world practice
|
Outcome Measures
Primary Outcome Measures
- Demographic characteristics at baseline [At baseline]
Patient demographics: age, age group and gender. Region of residence (North, Central, South). Socioeconomic status (SES): based on a score ranked with 1 (lowest) to 10 derived for commercial purposes by Points Location Intelligence using geographic information systems (GIS) and data such as expenditures related to retail chains, credit cards and housing. This score is highly correlated with SES measured by the Central Bureau of Statistics1. SES will be categorized into low (1-4), medium (5-6) and high (7-10).
- Clinical and Health Related Characteristics - BMI [At Baseline]
Body mass index (BMI) will be categorized using standard cut-points
- Clinical and Health Related Characteristics - chronic diseases [At Baseline]
Baseline chronic diseases will be identified using previously validated MHS automated chronic disease registries
- Clinical and Health Related Characteristics - Co-medications [At Baseline]
Minimum of 2 purchases within the 3 months period prior to index date
- Clinical and Health Related Characteristics - Menopausal status [At Baseline]
Pre-, peri- or post- menopausal.
- Clinical and Health Related Characteristics - Cancer History [At Baseline]
Cancer history will be obtained from National Cancer Registry data available through 2015 and MHS cancer registry data which draws from pathology reports and diagnoses linked to cancer medication approvals through 2017
- Clinical and Health Related Characteristics - Testing for germline BRCA mutation [At Baseline]
Testing for germline BRCA mutation carried out yes/no
- Treatment patterns - Lines of treatment [01 Jan 2018 through 31 Aug 2020]
Number (N) (%) patients receiving first, second- and third-line treatments by drug name and therapeutic group, median duration of each line of therapy, and number of cycles for each line of therapy. Treatment lines are defined according to the sequence of dispensed medications, with information captured both from pharmacy database, and from hospital medical records.
- Treatment Patterns - Index treatment regimen [01 Jan 2018 through 31 Aug 2020]
Palbociclib combination partner: Aromatase Inhibitors (AI) or fulvestrant; Subsequent therapy per lines of therapy
- Treatment Patterns - Dosing [01 Jan 2018 through 31 Aug 2020]
Dosing and dose changes, interruptions, delays, and discontinuations associated with palbociclib therapy
- Clinical outcomes for palbociclib - Disease Progression [01 Jan 2018 through 31 Aug 2020]
N (%) with disease progression at 6, 12 and 24 months
- Clinical Outcomes for Palbociclib - Duration of treatment [01 Jan 2018 through 31 Aug 2020]
Duration of treatment on palbociclib (Median time on treatment)
- Clinical Outcomes for Palbociclib - Time on treatment [01 Jan 2018 through 31 Aug 2020]
Time on treatment for subsequent line of therapy
- Clinical Outcomes for Palbociclib - Time to chemotherapy [01 Jan 2018 through 31 Aug 2020]
Time to chemotherapy after palbociclib treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
-
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.
-
At least 18 years of age at index date.
Exclusion Criteria:
Patients meeting any of the following criteria will not be included in the study:
- Patients that initiated HER2 inhibitors.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Pharmaceuticals Israel Ltd. | Herzliya Pituach | Israel | 4672509 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A5481160