A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel.

Metastatic Breast Cancer Clinical Trial

Official title:

DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04671615
• Other study ID #: A5481160
• Status: Completed
• Start date: December 6, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 559
• Est. completion date: January 1, 2023
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Breast Cancer

Intervention

Drug:
• palbociclib
As provided in real world practice

Locations

Country	Name	City	State
Israel	Pfizer Pharmaceuticals Israel Ltd.	Herzliya Pituach

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Categorized According to Type of Index Combination Treatment Regimen	Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment is palbociclib combination treatment.	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)
Primary	Duration of Index Treatment Per Type of Combination Treatment	Duration in months between the start and stop of therapy was reported. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.	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)
Primary	Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment	Number of participants categorized according to number of cycles of treatment included less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment	Number of participants were categorized according to initial palbociclib dose. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment	Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment	Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment included chemotherapy, everolimus plus exemestane, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.	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)
Primary	Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment	Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment	Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment	Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment	Number of participants who died following index treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment	Number of participants who died following index treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment	Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment	Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 6 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment	Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 12 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment	Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment. Number of participants who advanced and did not advance to a subsequent treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.	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)
Primary	Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment	Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.	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)
Primary	Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment	TTNT was defined as the interval between the start of the index treatment date and the date of the next-line treatment. Participants who did not advance to the next treatment were censored on the study end date or death, whichever occurred first. Index treatment is palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.	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)

External Links

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