Clinical trial NCT04671615: A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.
Official title: DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: hormone receptor
positive/human epidermal growth factor 2 - negative (HR+/HER2-)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


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.

Primary outcomes:
measure: Number of Participants Categorized According to Type of Index Combination Treatment Regimen
timeFrame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Duration of Index Treatment Per Type of Combination Treatment
timeFrame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment
timeFrame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment
timeFrame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment
timeFrame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment
timeFrame: Day 1 of subsequent treatment to last dose of subsequent treatment (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 6 (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 12 (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to Month 24 (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment
timeFrame: Up to Month 6 post index treatment discontinuation (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment
timeFrame: Up to Month 12 post index treatment discontinuation (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment
timeFrame: Up to Month 24 post index treatment discontinuation (during 01 January 2018 to 31 December 2020; from the retrospective data retrieved in approximately 10 months of the study)
measure: Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment
timeFrame: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
measure: Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment
timeFrame: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 31 December 2020 [approximately 36 months]; from the retrospective data retrieved and evaluated in approximately 10 months of the study)
Secondary outcomes:
Other outcomes:
Locations:
city: Herzliya Pituach
country: Israel
facility: Pfizer Pharmaceuticals Israel Ltd.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: