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CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.
The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).
Female patients aged 18 years old or more presenting the following conditions will be selected for the study:
Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC. | Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Treatment Pattern | Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel. | From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor | From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study | |
| Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor |
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Inclusion Criteria:
Exclusion Criteria:
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Female patients diagnosed with HR+/HER2- ABC/MBC who received a CDK4/6 inhibitor at Sinai Health, Canada during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Canada | Kirkland | Quebec | H9J2M5 | Canada |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 48 female participants were included in this study.
Participants diagnosed with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2)- advanced/metastatic breast cancer (ABC/MBC) between 01-Jan-2016 to 01-Jul-2021 and received a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) at Sinai Health were included in this retrospective study. Data were extracted from electronic health records until 01-Oct-2021. Available data was evaluated from 12-Oct-2022 to 28-Feb-2023 (approximately 4.5 months).
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| ID | Title | Description |
|---|---|---|
| FG000 | HR+/HER2- ABC/MBC Participants | Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | HR+/HER2- ABC/MBC Participants | Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Classified According to Treatment Pattern | Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel. | Analysis population included all eligible participants whose data were retrieved and observed in the study. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows. | Posted | Count of Participants | Participants | From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study |
|
From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HR+/HER2- ABC/MBC Participants | Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2023 | Feb 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2023 | Feb 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HR+/HER2- ABC/MBC Participants |
Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study. |
|
|
| Secondary | Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor | Analysis population included all eligible participants whose data were retrieved and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study |
|
|
|
| Secondary | Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor | Analysis population included all eligible participants whose data were retrieved and observed in the study. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study |
|
|
|
| 2 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D017437 |
| Skin and Connective Tissue Diseases |