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

NCT04671615 | Completed Results

• 2 other identifiers: A5481160NCT04671615
• Study Type: observational
• Target: 559
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer

Keywords

hormone receptor; positive/human epidermal growth factor 2 - negative (HR+/HER2-)

Outcome Measures

Primary Outcomes (17)

• 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 was palbociclib combination treatment. Index period was defined as duration in which participant initiated palbociclib combination treatment.

  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

• Duration of Index Treatment Per Type of Combination Treatment

  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.

  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 Index Treatment Per Type of Combination Treatment

  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.

  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 Initial Palbociclib Dose Per Type of Combination Treatment

  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.

  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 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 was palbociclib combination treatment.

  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

• 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 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.

  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

• 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 was palbociclib combination treatment.

  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 12 Per Type of Combination Treatment

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

  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 24 Per Type of Combination Treatment

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

  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 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 was palbociclib combination treatment.

  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 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 was palbociclib combination treatment.

  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 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 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 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.

  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 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.

  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 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.

  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

• 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]); data observed and evaluated during 18 months of this retrospective study

• 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 30 June 2022 [approximately 54 months]); data observed and evaluated during 18 months of this retrospective study

Study Arms (1)

Patients with metastatic, HR+/HER2- breast cancer.

Patients who initiated first or subsequent lines of treatment with palbociclib

Drug: palbociclib

Interventions

palbociclib DRUG

As provided in real world practice

Also known as: Ibrance

Patients with metastatic, HR+/HER2- breast cancer.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients that initiated HER2 inhibitors.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Pharmaceuticals Israel Ltd.

Herzliya Pituah, 4672509, Israel

Location

Related Publications (1)

• Moser SS, Mazursky OF, Shalev H, Apter L, Chodick G, Siegelmann-Danieli N. Real-world outcomes of patients with metastatic endocrine-responsive breast cancer receiving palbociclib-based combinations. Future Oncol. 2023 Jul;19(21):1473-1483. doi: 10.2217/fon-2023-0176. Epub 2023 Aug 2.

  PMID: 37529919 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

palbociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 17, 2020
• Study Start: December 6, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 10, 2025
• Results First Posted: August 18, 2023

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)