Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.

NCT ID: NCT05155566

Last Updated: 2024-01-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

847 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2021-03-12

Brief Summary

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To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination partner and labelled use in real world settings across Latin America.

Detailed Description

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Conditions

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Breast Cancer Metastatic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Breast Cancer Patients

HR + /HER2- Advanced/Metastatic Breast Cancer patients in Latin America

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Oncologist or gynecologist.
* Responsible for treating ≥4-10 (depending on country) ABC/MBC patients who meet the eligibility criteria.
* Agrees to participate in the study and complete the case report forms (CRFs) within the data collection period.


* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.
* Received palbociclib as a first line therapy.
* No prior or current enrolment in an interventional clinical trial for ABC/MBC.
* Minimum of six months of follow up data since palbociclib initiation.

Exclusion Criteria

* Qualified less than 2 years ago or more than 35 years ago.
* Participated in observational research for ABC/MBC in the last 3 months.
* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor as first line therapy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

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 country office

Buenos Aires, , Argentina

Site Status

Adelphi Mill, Bollington, Cheshire, SK10 5JB, UK

Bollington, Chesshire, United Kingdom

Site Status

Countries

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Argentina United Kingdom

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=A5481125

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Other Identifiers

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IRIS LATAM

Identifier Type: OTHER

Identifier Source: secondary_id

A5481125

Identifier Type: -

Identifier Source: org_study_id

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