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Trial record 1 of 1 for:    NCT04396626
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HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396626
Recruitment Status : Active, not recruiting
First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 28, 2020
First Posted Date May 20, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date November 18, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 18, 2020)
  • Proportion of patients receiving various cancer treatment regimens [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  • Proportion of patients receiving each therapy sequence across lines [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  • Proportion of patients receiving each starting dose and end dose for those on CDK4/6i combination therapy [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  • Proportion of patients that experience dose adjustment [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  • Proportion of patients that discontinue therapy [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
  • Real-world progression-free survival (rwPFS) [ Time Frame: 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.
  • Overall survival (OS) [ Time Frame: 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.
  • Real-world tumor response (rwTR) [ Time Frame: A/MBC diagnosis through end of study (assessed up to 36 months) ]
    Best overall response for each regimen
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HR+/ HER2- Advanced/ Metastatic Breast Cancer Real World Treatment Patterns and Outcomes
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will include adult patients 18 years or older, diagnosed with HR+/HER2- A/MBC who initiated CDK4/6i combination therapy with AI as the initial endocrine-based therapy on or after 2/3/2015 and before 4/1/2019.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Breast Cancer Patients
HR + /HER2- Advanced/Metastatic Breast Cancer patients in U.S.A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 18, 2020)
1
Original Actual Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.

  5. 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).
  6. 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04396626
Other Study ID Numbers A5481144
Concerto ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2020