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Demographics, Characteristics, Treatment Patterns and Clinical Outcomes of Palbociclib Treated Patients in Israel

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ClinicalTrials.gov Identifier: NCT04671615
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date November 24, 2020
First Posted Date December 17, 2020
Last Update Posted Date March 22, 2021
Actual Study Start Date December 6, 2020
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2020)
  • Demographic characteristics at baseline [ Time Frame: At baseline ]
    • Patient demographics: age, age group and gender.
    • Region of residence (North, Central, South).
    • Socioeconomic status (SES): based on a score ranked with 1 (lowest) to 10 derived for commercial purposes by Points Location Intelligence using geographic information systems (GIS) and data such as expenditures related to retail chains, credit cards and housing. This score is highly correlated with SES measured by the Central Bureau of Statistics1. SES will be categorized into low (1-4), medium (5-6) and high (7-10).
  • Clinical and Health Related Characteristics - BMI [ Time Frame: At Baseline ]
    Body mass index (BMI) will be categorized using standard cut-points
  • Clinical and Health Related Characteristics - chronic diseases [ Time Frame: At Baseline ]
    Baseline chronic diseases will be identified using previously validated MHS automated chronic disease registries
  • Clinical and Health Related Characteristics - Co-medications [ Time Frame: At Baseline ]
    Minimum of 2 purchases within the 3 months period prior to index date
  • Clinical and Health Related Characteristics - Menopausal status [ Time Frame: At Baseline ]
    Pre-, peri- or post- menopausal.
  • Clinical and Health Related Characteristics - Cancer History [ Time Frame: At Baseline ]
    Cancer history will be obtained from National Cancer Registry data available through 2015 and MHS cancer registry data which draws from pathology reports and diagnoses linked to cancer medication approvals through 2017
  • Clinical and Health Related Characteristics - Testing for germline BRCA mutation [ Time Frame: At Baseline ]
    Testing for germline BRCA mutation carried out yes/no
  • Treatment patterns - Lines of treatment [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Number (N) (%) patients receiving first, second- and third-line treatments by drug name and therapeutic group, median duration of each line of therapy, and number of cycles for each line of therapy. Treatment lines are defined according to the sequence of dispensed medications, with information captured both from pharmacy database, and from hospital medical records.
  • Treatment Patterns - Index treatment regimen [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Palbociclib combination partner: Aromatase Inhibitors (AI) or fulvestrant; Subsequent therapy per lines of therapy
  • Treatment Patterns - Dosing [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Dosing and dose changes, interruptions, delays, and discontinuations associated with palbociclib therapy
  • Clinical outcomes for palbociclib - Disease Progression [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    N (%) with disease progression at 6, 12 and 24 months
  • Clinical Outcomes for Palbociclib - Duration of treatment [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Duration of treatment on palbociclib (Median time on treatment)
  • Clinical Outcomes for Palbociclib - Time on treatment [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Time on treatment for subsequent line of therapy
  • Clinical Outcomes for Palbociclib - Time to chemotherapy [ Time Frame: 01 Jan 2018 through 31 Aug 2020 ]
    Time to chemotherapy after palbociclib treatment
Original Primary Outcome Measures Same as current
Change History
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 Demographics, Characteristics, Treatment Patterns and Clinical Outcomes of Palbociclib Treated Patients in Israel
Official Title DEMOGRAPHICS, PATIENT CHARACTERISTICS, TREATMENT PATTERNS AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH PALBOCICLIB IN A REAL LIFE SETTING IN ISRAEL
Brief Summary This non-interventional study aims to describe patient demographics, clinical characteristics, clinical outcomes and treatment patterns of adult breast cancer patients who have initiated palbociclib combination treatment as per the national basket of health services in January 2018 until August 2020 for all lines of therapy. This is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.
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 is a population based retrospective database study that will include patients with metastatic, HR+/ HER2- breast cancer and who initiated first or subsequent lines of treatment with palbociclib. Data will be available from Maccabi Healthcare Services (MHS) database in Israel for patients who received approval for treatment with palbociclib since 01 January 2018 until 31 August 2020.
Condition Metastatic Breast Cancer
Intervention Drug: palbociclib
As provided in real world practice
Study Groups/Cohorts Patients with metastatic, HR+/HER2- breast cancer.
Patients who initiated first or subsequent lines of treatment with palbociclib
Intervention: Drug: palbociclib
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 Recruiting
Estimated Enrollment
 (submitted: December 15, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. A diagnosis of metastatic breast cancer, based on the National/MHS cancer registry.
  2. Newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting.
  3. Available data on palbociclib treatment for at least 6 months.
  4. Continuous healthcare plan enrolment in MHS for at least one year before index date.
  5. At least 18 years of age at index date.

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Patients that initiated HER2 inhibitors.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04671615
Other Study ID Numbers A5481160
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 March 2021