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Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

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: NCT05399329
Recruitment Status : Active, not recruiting
First Posted : June 1, 2022
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 26, 2022
First Posted Date June 1, 2022
Last Update Posted Date December 16, 2022
Actual Study Start Date April 20, 2022
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2022)
  • Real-World Progression-Free Survival (rwPFS) of palbociclib plus ET as first line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2022)
  • Landmark overall survival (OS) (defined from palbociclib initiation to death) of palbociclib plus ET as first line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Landmark OS (defined from palbociclib initiation to death)of palbociclib plus ET as second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Landmark OS (defined from treatment initiation of first line to death) when palbociclib plus ET were used as second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Time to treatment discontinuation (TTD) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • TTD of first subsequent treatment for HR+/HER2- ABC patients who were treated with palbociclib plus ET [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Time to chemotherapy (TTC: defined as the time from treatment initiation of first or second line for HR+/HER2- ABC to first use of chemotherapy) [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Real-world objective response rate (rwORR) of palbociclib plus ET as first line or second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Demographic of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Clinical characteristics of HR+/HER2- ABC patients who were treated with palbociclib plus ET in routine clinical practice in Japan [ Time Frame: 15 December 2017 to 31 August 2023 ]
  • Treatment patterns of palbociclib plus ET in routine clinical practice in Japan [ Time Frame: 15 December 2017 to 31 August 2023 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan
Official Title Retrospective, Multicenter, Observational Study to Evaluate Real-World Effectiveness of Palbociclib Plus Endocrine Therapy in Japanese Patients With HR+/HER2- Advanced Breast Cancer in First Line or Second Line Settings
Brief Summary This is a retrospective, multicenter, observational study in Japan by medical record review of advanced breast cancer (ABC) patients who have received palbociclib plus endocrine therapy (ET) as first line or second line setting. For the purposes of this study, analyses will be descriptive in nature. No formal hypothesis testing is planned.
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 This study uses secondary data of multiple sites by utilizing medical record review approach for those who have been diagnosed with ABC in Japan.
Condition Breast Cancer
Intervention
  • Drug: Palbociclib
    Palbociclib plus ET as first-line/second-line treatment for hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) ABC
  • Drug: Endocrine therapy
    Palbociclib plus ET as first-line/second-line treatment for HR+/HER2- ABC
Study Groups/Cohorts Not Provided
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: December 15, 2022)		 688
Original Estimated Enrollment
 (submitted: May 26, 2022)		 500
Estimated Study Completion Date June 30, 2024
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of HR+/HER2- ABC
  • Age of 20 years or older at diagnosis of ABC
  • Patients that received palbociclib plus ET in the first line or second line
  • Patients who meet the criteria regarding the medical record below:
  • Patients with any medical records (regardless of palbociclib use) for more than 6 months from palbociclib initiation OR
  • Patients with any medical records for less than 6 months from palbociclib initiation AND who had specific events (death, disease progression, or treatment discontinuation of palbociclib due to adverse events) in the available records

Exclusion Criteria:

  • Patients who received chemotherapy as first line treatment.
  • Patients who have previously participated or are participating in any interventional clinical trials that include investigational or marketed products.

(Interventional clinical trials for early breast cancer and later line after palbociclib will be acceptable, Besides, patients participating in other investigator-initiated research or noninterventional studies can be included as long as their standard of care is not altered by the study.)
Sex/Gender
Sexes Eligible for Study: All
Ages 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT05399329
Other Study ID Numbers A5481166
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.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor Pfizer
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2022