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

NCT ID: NCT04671615

Last Updated: 2025-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

559 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-06

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

Patients who initiated first or subsequent lines of treatment with palbociclib

palbociclib

Intervention Type DRUG

As provided in real world practice

Interventions

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palbociclib

As provided in real world practice

Intervention Type DRUG

Other Intervention Names

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Ibrance

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Pharmaceuticals Israel Ltd.

Herzliya Pituah, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 37529919 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481160

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

Other Identifiers

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NCT04671615

Identifier Type: REGISTRY

Identifier Source: secondary_id

A5481160

Identifier Type: -

Identifier Source: org_study_id

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