RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.

NCT04460898

Last updated date
Study Location
Pfizer United States
New York, New York, 10017, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + 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. Diagnosed with locoregional recurrent or metastatic female breast cancer.

2. Pathologically confirmed HR-positive/HER2-negative diagnosis.

3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.

2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.

4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.

5. ≥18 year old at initiation of palbociclib.

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


- No exclusion criteria will be imposed for the selection of patients.

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Advanced Information
Descriptive Information
Brief Title RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Official Title Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
Brief Summary This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
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 aged 18 years and older, diagnosed with HR+/HER2- mBC and received treatment with Palbociclib in combination with letrozole as initial endocrine-therapy for advanced/metastatic breast cancer.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Breast Cancer Patients
HR+/HER2- metastatic breast cancer patients in the US.
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 Completed
Actual Enrollment
 (submitted: July 6, 2020)
1
Original Actual Enrollment Same as current
Actual Study Completion Date June 24, 2019
Actual Primary Completion Date June 24, 2019   (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. Diagnosed with locoregional recurrent or metastatic female breast cancer.
    2. Pathologically confirmed HR-positive/HER2-negative diagnosis.
    3. Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:

      1. Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
      2. At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
    4. Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
    5. ?18 year old at initiation of palbociclib.

      Exclusion Criteria:

  • No exclusion criteria will be imposed for the selection of patients.
Sex/Gender
Sexes Eligible for Study:Female
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 NCT04460898
Other Study ID Numbers A5481123
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 July 2020