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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

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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

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Palbociclib Drug: Endocrine therapy

Study Design
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Study Type : Observational
Actual Enrollment : 688 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : April 20, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

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

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. rePFS of palbociclib plus ET as second line treatment for HR+/HER2- ABC [ Time Frame: 15 December 2017 to 31 August 2023 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Treatment patterns of palbociclib plus ET in routine clinical practice in Japan [ Time Frame: 15 December 2017 to 31 August 2023 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.)

Contacts and Locations
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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): NCT05399329


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05399329    
Other Study ID Numbers: A5481166
First Posted: June 1, 2022    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 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:
Retrospective
Multicenter
Observational
Effectiveness
Real-world progression free survival
Palbociclib
 Endocrine therapy
Japan
Hormone receptor positive/ human epidermal growth factor negative (HR+/HER2-)
Advanced Breast Cancer
First-line therapy
Second-Line therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action