Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
NCT04460911
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Washington, District of Columbia
- Baltimore, Maryland
- Badalona, Barcelona
- Madrid,
- Valencia,
- Oporto,
- Columbus, Ohio
- Mobile, Alabama
- Mobile, Alabama
- Anchorage, Alaska
- Anchorage, Alaska
- Phoenix, Arizona
- Greenbrae, California
- Greenbrae, California
- La Jolla, California
- Los Angeles, California
- Oakland, California
- Palo Alto, California
- Roseville, California
- Sacramento, California
- San Diego, California
- San Diego, California
- San Diego, California
- San Francisco, California
- San Francisco, California
- San Leandro, California
- Santa Clara, California
- South San Francisco, California
- Stanford, California
- Vallejo, California
- Walnut Creek, California
- Denver, Colorado
- Hartford, Connecticut
- New Britain, Connecticut
- Newark, Delaware
- Washington, District of Columbia
- Washington, District of Columbia
- Clearwater, Florida
- Jacksonville, Florida
- Miami Beach, Florida
- Miami, Florida
- Orlando, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Chicago, Illinois
- Chicago, Illinois
- Decatur, Illinois
- Harvey, Illinois
- Joliet, Illinois
- Park Ridge, Illinois
- Peoria, Illinois
- Rockford, Illinois
- Skokie, Illinois
- Skokie, Illinois
- Urbana, Illinois
- Indianapolis, Indiana
- Muncie, Indiana
- Ames, Iowa
- Ames, Iowa
- Cedar Rapids, Iowa
- Des Moines, Iowa
- Waterloo, Iowa
- Lexington, Kentucky
- Louisville, Kentucky
- New Orleans, Louisiana
- Bangor, Maine
- Scarborough, Maine
- Annapolis, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Baltimore, Maryland
- Bethesda, Maryland
- Salisbury, Maryland
- Silver Spring, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Lowell, Massachusetts
- Plymouth, Massachusetts
- Ann Arbor, Michigan
- Grand Rapids, Michigan
- Livonia, Michigan
- Duluth, Minnesota
- Rochester, Minnesota
- Rochester, Minnesota
- Saint Cloud, Minnesota
- Saint Louis Park, Minnesota
- Saint Louis Park, Minnesota
- Kansas City, Missouri
- Rolla, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Springfield, Missouri
- Omaha, Nebraska
- Concord, New Hampshire
- Hooksett, New Hampshire
- Lebanon, New Hampshire
- Lebanon, New Hampshire
- Englewood, New Jersey
- Hackensack, New Jersey
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- Bronx, New York
- Buffalo, New York
- East Syracuse, New York
- Jamaica, New York
- New Hyde Park, New York
- New York, New York
- New York, New York
- New York, New York
- Oneonta, New York
- Syracuse, New York
- Charlotte, North Carolina
- Durham, North Carolina
- Greensboro, North Carolina
- Pinehurst, North Carolina
- Rapid City, North Dakota
- Cleveland, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Mayfield Heights, Ohio
- Lawton, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Portland, Oregon
- Dunmore, Pennsylvania
- Hershey, Pennsylvania
- Lancaster, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- Wyomissing, Pennsylvania
- York, Pennsylvania
- Providence, Rhode Island
- Providence, Rhode Island
- Columbia, South Carolina
- Aberdeen, South Dakota
- Rapid City, South Dakota
- Sioux Falls, South Dakota
- Nashville, Tennessee
- Nashville, Tennessee
- Houston, Texas
- Houston, Texas
- Houston, Texas
- Laredo, Texas
- Salt Lake City, Utah
- Fairfax, Virginia
- Richmond, Virginia
- Charleston, West Virginia
- Appleton, Wisconsin
- Green Bay, Wisconsin
- La Crosse, Wisconsin
- Madison, Wisconsin
- Milwaukee, Wisconsin
- Milwaukee, Wisconsin
- Racine, Wisconsin
- Waukesha, Wisconsin
- Waukesha, Wisconsin
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 |
| ||||
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 | 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:
Exclusion Criteria:
| ||||
Sex/Gender |
| ||||
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 |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | July 2020 |