Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.

NCT04460911

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
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients with a documented diagnosis of hormone receptor-positive (estrogen receptor-positive or progesterone receptor-positive), human epidermal growth factor receptor 2-negative mBC.

2. Aged 18 years at initial recorded diagnosis of mBC.

3. Initiated one of the following qualifying regimens within the USON during the study identification period:

1. Palbociclib combination therapy with an aromatase inhibitor (letrozole, exemestane, or anastrozole) among patients as first-line therapy in the advanced or metastatic setting;

2. Palbociclib combination therapy with fulvestrant following as first-line or beyond therapy in the advanced or metastatic setting;

3. Aromatase inhibitor (letrozole, exemestane or anastrozole) monotherapy as first-line treatment in the advanced or metastatic setting;

4. Fulvestrant monotherapy as first-line or beyond therapy in the advanced or metastatic setting.

4. Received care at a USON site(s) utilizing the full EHR capacities of iKM at the time of treatment.

5. EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.

6. During the study observation period, patients observed with at least 2 visits after the index date.

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


1. Enrollment in an interventional clinical trial during the study observation period
since clinical trial participants may have clinical scenarios that deviate from the
population of interest.


2. Among the Pb-AI and AI mono cohorts, evidence of prior treatment with other CDK 4/6
inhibitors (ribociclib or abemaciclib), aromatase inhibitors (letrozole, exemestane,
or anastrozole), tamoxifen, raloxifene, toremifene, or fulvestrant in the advanced or
metastatic setting.


3. Among the Pb-FUL and FUL mono cohorts, evidence of prior treatment with CDK 4/6
inhibitors (ribociclib or abemaciclib) in the advanced or metastatic setting.


4. Receipt of treatment indicated for another primary cancer during the study observation
period or history of another primary cancer within the USON iKM EHR database.

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Advanced Information
Descriptive Information
Brief Title Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
Official Title Treatment Patterns And Clinical Outcomes Among Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (Mbc) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting
Brief Summary By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of a large community oncology network in the United States.
Detailed Description Study observation period: 01 February 2015 - 30 September 2019.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients With Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (Mbc) Receiving Palbociclib Combination Therapy, Endocrine Monotherapy Or Fulvestrant Monotherapy In The US Community Oncology Setting
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts
  • Cohort 1a (Pb-AI)
    Patients who initiated treatment with an aromatase inhibitor (letrozole, exemestane, or anastrozole) palbociclib combination therapy as first-line treatment in the advanced or metastatic setting.
  • Cohort 1b (Pb-FUL)
    Patients who initiated palbociclib-fulvestrant combination therapy as first-line or beyond therapy in the advanced or metastatic setting.
  • Cohort 2a (AI mono)
    Patients who initiated treatment with an aromatase inhibitor (letrozole, exemestane, or anastrozole) as a monotherapy as first-line treatment in the advanced or metastatic setting.
  • Cohort 2b (FUL mono)
    Patients who received fulvestrant monotherapy as first-line or beyond therapy in the advanced or metastatic setting.
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: July 6, 2020)
1
Original Actual Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patients with a documented diagnosis of hormone receptor-positive (estrogen receptor-positive or progesterone receptor-positive), human epidermal growth factor receptor 2-negative mBC.
  2. Aged 18 years at initial recorded diagnosis of mBC.
  3. Initiated one of the following qualifying regimens within the USON during the study identification period:

    1. Palbociclib combination therapy with an aromatase inhibitor (letrozole, exemestane, or anastrozole) among patients as first-line therapy in the advanced or metastatic setting;
    2. Palbociclib combination therapy with fulvestrant following as first-line or beyond therapy in the advanced or metastatic setting;
    3. Aromatase inhibitor (letrozole, exemestane or anastrozole) monotherapy as first-line treatment in the advanced or metastatic setting;
    4. Fulvestrant monotherapy as first-line or beyond therapy in the advanced or metastatic setting.
  4. Received care at a USON site(s) utilizing the full EHR capacities of iKM at the time of treatment.
  5. EHR data available from the USON site(s) where the patient received treatment are accessible for research purposes.
  6. During the study observation period, patients observed with at least 2 visits after the index date.

Exclusion Criteria:

  1. Enrollment in an interventional clinical trial during the study observation period since clinical trial participants may have clinical scenarios that deviate from the population of interest.
  2. Among the Pb-AI and AI mono cohorts, evidence of prior treatment with other CDK 4/6 inhibitors (ribociclib or abemaciclib), aromatase inhibitors (letrozole, exemestane, or anastrozole), tamoxifen, raloxifene, toremifene, or fulvestrant in the advanced or metastatic setting.
  3. Among the Pb-FUL and FUL mono cohorts, evidence of prior treatment with CDK 4/6 inhibitors (ribociclib or abemaciclib) in the advanced or metastatic setting.
  4. Receipt of treatment indicated for another primary cancer during the study observation period or history of another primary cancer within the USON iKM EHR database.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, 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 NCT04460911
Other Study ID Numbers A5481128
US oncology ( Other Identifier: Alias Study Number )
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