TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.
NCT ID: NCT04498481
Last Updated: 2020-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1 participants
OBSERVATIONAL
2018-03-01
2018-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Breast cancer patients
HR+/HER2- advanced/metastatic breast cancer patients in the USA.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Female.
* Diagnosis of female breast cancer with evidence of metastatic disease or advanced disease.
* Diagnosis (confirmed by clinical review) of advanced or metastatic breast cancer at any time, defined as breast cancer at stage IIIb, stage IIIc, or stage IV or identified as having distant metastasis.
* Indication in the record of ER or PR positive disease, or absence of any indication of ER and PR negative disease (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).
* Receipt of a palbociclib plus aromatase inhibitor (AI) or palbociclib plus fulvestrant regimen on 2/3/2015 or later in the advanced and metastatic setting. Data collection will prioritize accrual of patients with 1L use of palbociclib plus AI and with 2L use of palbociclib plus fulvestrant before collecting other use of palbociclib users.
* Age greater than or equal to 18 years at A/MBC diagnosis.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer United States
New York, New York, United States
Countries
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References
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Robert N, Chen C, Doan J, Venkatasetty D, Espirito JL, Aguilar KM. Real-world study of patients with HR+/ HER2- metastatic breast cancer treated with palbociclib and fulvestrant. Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5481095
Identifier Type: -
Identifier Source: org_study_id
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