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.

Breast Cancer Clinical Trial

Official title:

TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB PLUS AROMATASE INHIBITOR OR PALBOCICLIB PLUS FULVESTRANT AS TREATMENT OF HORMONE RECEPTOR POSITIVE (HR+)/HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE (HER2-) ADVANCED OR METASTATIC BREAST CANCER IN A REAL WORLD COMMUNITY ONCOLOGY SETTING

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04498481
• Other study ID #: A5481095
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: August 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

-There are no exclusion criteria for this study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Pfizer United States	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving various cancer treatment regimens		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients receiving each therapy sequence across lines		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Treatment persistence		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Progression Free Survival (PFS)		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Overall Survival (OS)		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Tumor response rate		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients that experience dose adjustment		A/MBC diagnosis through end of study (assessed up to 24 months)
Primary	Proportion of patients who discontinue therapy		A/MBC diagnosis through end of study (assessed up to 24 months)

External Links

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