Clinical trial NCT04498481: 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.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-04
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with AI or fulvestrant on or after 2/3/2015.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients receiving various cancer treatment regimens
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients receiving each therapy sequence across lines
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Treatment persistence
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Progression Free Survival (PFS)
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Overall Survival (OS)
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Tumor response rate
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients that experience dose adjustment
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
measure: Proportion of patients who discontinue therapy
timeFrame: A/MBC diagnosis through end of study (assessed up to 24 months)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer United States
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: