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

NCT04671615

Last updated date
Study Location
Pfizer Pharmaceuticals Israel Ltd.
Herzliya Pituach, , 4672509, Israel
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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


1. Patients that initiated HER2 inhibitors.

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Advanced Information
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 Center1-800-718-1021[email protected]
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021