Skip to main content
OpenTrials
Completed

NCT Number: NCT04176354

Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Pfizer

New York, 10017, United States

About this study

Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female sex
  • At least 18 years old at MBC diagnosis
  • Diagnosis of MBC at any point in patient history
  • ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
  • Confirmation of metastatic disease
  • At least 2 document clinical visits
  • Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
  • HR+/HER2-
  • HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
  • HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
  • Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion criteria

  • Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC
  • First structured activity greater than 90 days after MBC diagnostic date
  • Treatment with a CDK4/6 inhibitor as part of a clinical trial

Treatment and study plan

Palbociclib + an aromatase inhibitor

Drug

Palbociclib + an aromatase inhibitor therapy

Palbociclib + Letrozole

Drug

Palbociclib + Letrozole therapy

letrozole

Drug

Letrozole monotherapy

Primary outcomes

  1. Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method

    Time frame: From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.

Secondary outcomes

  1. Overall Survival (OS): Using Kaplan-Meier Method

    Time frame: From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.

  2. Number of Participants With Real World Tumour Response (rwTR)

    Time frame: From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI.

  3. Response Rate

    Time frame: From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants.

  4. Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method

    Time frame: From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.

  5. Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method

    Time frame: From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.

  6. Time to First Use of Chemotherapy: Using Kaplan-Meier Method

    Time frame: From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)

    The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 25, 2019
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.