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

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ClinicalTrials.gov Identifier: NCT04176354
Recruitment Status : Active, not recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Palbociclib + an aromatase inhibitor Drug: Palbociclib + Letrozole Drug: Letrozole

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official 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
Actual Study Start Date : October 27, 2019
Estimated Primary Completion Date : October 27, 2021
Estimated Study Completion Date : October 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Palbociclib + an aromatase inhibitor
Adult metastatic breast cancer patients who initiated Palbociclib + an aromatase inhibitor as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Drug: Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy

Palbociclib + Letrozole
Adult metastatic breast cancer patients who initiated Palbociclib +Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Drug: Palbociclib + Letrozole
Palbociclib + Letrozole therapy

Letrozole
Adult metastatic breast cancer patients who initiated Letrozole as first line therapy between Feb 3, 2015 to 3 months prior to date of data cutoff in the Flatiron Health Analytic Database.
Drug: Letrozole
Letrozole monotherapy




Primary Outcome Measures :
  1. Real-world progression free survival (rwPFS) [ Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months ]
    Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 52 months ]
    Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.

  2. Real-world tumor response (rwTR) [ Time Frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months ]
    Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment

  3. Time to next line of therapy [ Time Frame: From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months ]
    Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months

  4. Time to first use of chemotherapy [ Time Frame: From date of index treatemnt to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months ]
    Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HR+/HER2- MBC female adult patients treated with Palbociclib + AI or Letrozole alone between February2015 and end of 2018 or data cut-off date
Criteria

Inclusion Criteria:

  1. Female sex
  2. At least 18 years old at MBC diagnosis
  3. Diagnosis of MBC at any point in patient history

    1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC
    2. Confirmation of metastatic disease
    3. At least 2 document clinical visits
    4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents
  4. HR+/HER2-

    1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
    2. 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
  5. Palbociclib + AI as initial endocrine based 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176354


Locations
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United States, New York
Pfizer
New York, New York, United States, 10017
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04176354     History of Changes
Other Study ID Numbers: A5481122
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pfizer:
Breast cancer
Palbociclib
Real-world data
Retrospective study
Effectiveness
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Palbociclib
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Protein Kinase Inhibitors