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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-07-01

Brief Summary

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This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.

Detailed Description

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Conditions

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Breast Cancer

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 the USA.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients who are represented in the Vector Oncology Data Warehouse who meet all of the following criteria will be eligible for inclusion in the study.

* 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.
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 United States

New York, New York, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 39810652 (View on PubMed)

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481095

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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