We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Real-World Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05361655
Recruitment Status : Recruiting
First Posted : May 5, 2022
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Analytic Database to compare effectiveness (i.e., overall survival) of first line palbociclib + aromatase inhibitor (AI) versus AI alone treatment in postmenopausal women or men with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (MBC) in the United States clinical practices

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

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-World Treatment Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as 1st Line Therapy in Metastatic Breast Cancer
Actual Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 20, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Palbociclib

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 March 31, 2020 in the Flatiron Health Analytic Database.
 Drug: Palbociclib + an aromatase inhibitor
Palbociclib + an aromatase inhibitor therapy
Aromatase inhibitor
Adult metastatic breast cancer patients who initiated an aromatase inhibitor as first line therapy between Feb 3, 2015 to March 31, 2020 in the Flatiron Health Analytic Database.
 Drug: Aromatase inhibitor
Aromatase inhibitor therapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Overall survival [ Time Frame: From date of index treatment until date of death from any cause or end of study, whichever came first, assessed up to 68 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


Secondary 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 68 months ]
    rwPFS2 is the number of months from start of palbociclib + AI or AI alone to disease progression (based on clinical assessment or by radiographic scan/tissue biopsy) on the 2nd line of therapy or death from any cause, whichever occurred first

  2. Real-world tumor responses (rwTR) [ Time Frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 68 months ]
    Real-world best responses are assessed based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment after 1 month of index treatment initiation

  3. Initial dose of palbociclib [ Time Frame: From date of index treatment up to 68 months ]
    Describe initial dose of palbociclib treatment pattern

  4. Time to dose adjustment [ Time Frame: From date of index treatment to dose adjustment, assessed up to 68 months ]
  5. Duration of treatment [ Time Frame: From date of index treatment to end of the treatment, death, or end of study, whichever came first, assessed up to 68 months ]
  6. Time to subsequent treatments [ Time Frame: From date of index treatment to subsequent treatment, death, or end of study, whichever came first, assessed up to 68 months ]
  7. Time to chemotherapy [ Time Frame: From date of index treatment to subsequent chemotherapy, death, or end of study, whichever came first, assessed up to 68 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HR+/HER2- MBC adult patients treated with Palbociclib + AI or AI alone between February2015 and September, 2020
Criteria

Inclusion Criteria:

  • Confirmed HR+/HER2- status after MBC diagnosis.
  • Received palbociclib + AI or AI as first-line therapy

Exclusion Criteria:

  • Evidence of prior treatment with other CDK4/6I, AI, 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT05361655


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Layout table for location information
United States, New York
10017 Recruiting
New York, New York, United States, 10017
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05361655    
Other Study ID Numbers: A5481151
First Posted: May 5, 2022    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
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.
Keywords provided by Pfizer:
cyclin-dependent kinase 4/6i (CDK4/6i)
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Palbociclib
Aromatase Inhibitors
Antineoplastic Agents
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs