HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT04396626
Collaborator
(none)
975
Enrollment
1
Location
14.9
Actual Duration (Months)
65.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective, observational study that will document the treatment patterns and clinical outcomes of patients diagnosed with HR+/HER2- A/MBC who received CDK4/6i combination therapy with aromatase inhibitors (AI) as the initial endocrine-based therapy in the A/MBC setting.

Condition or DiseaseIntervention/TreatmentPhase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    975 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2- Advanced/Metastatic Breast Cancer Receiving CDK4/6i + Aromatase Inhibitor (AI) Combination Therapy as Initial Endocrine-based Treatment
    Actual Study Start Date :
    Nov 18, 2019
    Actual Primary Completion Date :
    Feb 12, 2021
    Actual Study Completion Date :
    Feb 12, 2021

    Arms and Interventions

    ArmIntervention/Treatment
    Breast Cancer Patients

    HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients receiving various cancer treatment regimens [A/MBC diagnosis through end of study (assessed up to 36 months)]

    2. Proportion of patients receiving each therapy sequence across lines [A/MBC diagnosis through end of study (assessed up to 36 months)]

    3. Proportion of patients receiving each starting dose and end dose for those on CDK4/6i combination therapy [A/MBC diagnosis through end of study (assessed up to 36 months)]

    4. Proportion of patients that experience dose adjustment [A/MBC diagnosis through end of study (assessed up to 36 months)]

    5. Proportion of patients that discontinue therapy [A/MBC diagnosis through end of study (assessed up to 36 months)]

    6. Real-world progression-free survival (rwPFS) [A/MBC diagnosis through end of study (assessed up to 36 months)]

      Defined as the time from the index date to disease progression, death, or end of record or end of data availability, whichever comes first.

    7. Overall survival (OS) [A/MBC diagnosis through end of study (assessed up to 36 months)]

      Overall survival is defined as the time between the index date to disease progression, death due to any cause or end of data availability, whichever comes first.

    8. Real-world tumor response (rwTR) [A/MBC diagnosis through end of study (assessed up to 36 months)]

      Best overall response for each regimen

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Female or male sex.

    2. Diagnosis (confirmed by clinical review) of A/MBC, defined as breast cancer at stage IIIB, stage IIIC, stage IV or identified as having distant metastasis.

    3. Age ≥18 years at A/MBC diagnosis.

    4. Initiated a CDK4/6i in combination with an AI as initial endocrine-based therapy after A/MBC diagnosis on or after 2/3/2015 and before 4/1/2019.

    •Note that the date of the start of the inclusion period reflects the month that the first CDK4/6i (ie, Palbociclib) received U.S. FDA approval.

    1. Evidence of ER or PR positive disease, or absence of any indication of ER and PR negative disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of ER/PR+ status as long as ER/PR- indication is not present).

    2. Evidence of HER2 negative disease, or absence of any indication of HER2 positive disease closest to A/MBC diagnosis (ie, patients are eligible without affirmative indication of HER2- status as long as HER2+ indication is not present).

    Exclusion Criteria:
    1. Enrollment in an interventional clinical trial for A/MBC during the study observation period.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Pfizer United StatesNew YorkNew YorkUnited States10017

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04396626
    Other Study ID Numbers:
    • A5481144
    • Concerto
    First Posted:
    May 20, 2020
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2021