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Completed

NCT Number: 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.

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Pharmaceuticals Israel Ltd.

Herzliya Pituah, 4672509, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palbociclib

Drug

As provided in real world practice

Other names: Ibrance

Primary outcomes

  1. Number of Participants Categorized According to Type of Index Combination Treatment Regimen

    Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study

    Number of participants were classified on the basis of type of combination treatment along with palbociclib as first line therapy. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.

  2. Duration of Index Treatment Per Type of Combination Treatment

    Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Duration in months between the start and stop of therapy was reported. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

  3. Number of Participants Categorized According to Number of Cycles of Index Treatment Per Type of Combination Treatment

    Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Number of participants categorized according to number of cycles of treatment including less than or equal to (<=) 6, greater than (>) 6 to 11, >11 to 20 and >20 cycles were reported. Index treatment was palbociclib combination treatment.

  4. Number of Participants Categorized According to Initial Palbociclib Dose Per Type of Combination Treatment

    Time frame: Day 1 of index treatment (any day from 01 January 2018 to 30 June 2020 [index period]), data observed and evaluated during 18 months of this retrospective study

    Number of participants were categorized according to initial palbociclib dose. Index treatment was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.

  5. Number of Participants With Modification (Reduction) in Initial Palbociclib Dose Per Type of Combination Treatment

    Time frame: Day 1 of index treatment till discontinuation of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Number of participants who had a reduction in initial palbociclib dose were reported. Index treatment was palbociclib combination treatment.

  6. Time on Treatment for Subsequent Treatment After Palbociclib Therapy Per Type of Combination Treatment

    Time frame: Day 1 of subsequent treatment till last dose of subsequent treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Subsequent treatment after palbociclib therapy was the regimen received by participants following discontinuation from the palbociclib treatment and included chemotherapy, everolimus, fulvestrant and other. The duration between the start and stop of the post-palbociclib treatment was reported in this outcome measure. Index treatment was palbociclib combination treatment. Kaplan-Meier method was used for the assessment of this outcome measure.

  7. Percentage of Participants With Ongoing Index Treatment at Month 6 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Percentage of participants with ongoing index treatment at Month 6 were reported. Index treatment was palbociclib combination treatment.

  8. Percentage of Participants With Ongoing Index Treatment at Month 12 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Percentage of participants with ongoing index treatment at Month 12 were reported. Index treatment was palbociclib combination treatment.

  9. Percentage of Participants With Ongoing Index Treatment at Month 24 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Percentage of participants with ongoing index treatment at Month 24 were reported. Index treatment was palbociclib combination treatment.

  10. Number of Participants Who Died Following Initiation of Index Treatment up to Month 6 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Number of participants who died following index treatment up to Month 6 were reported. Index treatment was palbociclib combination treatment.

  11. Number of Participants Who Died Following Initiation of Index Treatment up to Month 12 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Number of participants who died following index treatment up to Month 12 were reported. Index treatment was palbociclib combination treatment.

  12. Number of Participants Who Died Following Initiation of Index Treatment up to Month 24 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    Number of participants who died following index treatment up to Month 24 were reported. Index treatment is palbociclib combination treatment.

  13. Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 6 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 6 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    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.

  14. Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 12 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 12 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    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.

  15. Number of Participants Who Advanced and Did Not Advance to a Subsequent Treatment up to Month 24 Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to Month 24 of index treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    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.

  16. Time to Initiation of Chemotherapy After Cessation of Initial Palbociclib Therapy Per Type of Combination Treatment

    Time frame: From cessation of index treatment up to initiation of chemotherapy (during 01 January 2018 to 31 December 2020 [approximately 36 months]); data observed and evaluated during 18 months of this retrospective study

    Time to initiation of chemotherapy was the duration from end of index treatment up to start of chemotherapy. Index treatment is palbociclib combination treatment.

  17. Time to Initiation of Next Treatment (TTNT) From Initiation of Palbociclib Treatment Per Type of Combination Treatment

    Time frame: Day 1 of index treatment up to initiation of next treatment (during 01 January 2018 to 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2020
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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