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This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a first or later line of therapy. Patients will be identified from the Flatiron Electronic Health Record database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talazoparib-treated adults with HER2- gBRCAm mBC | Adult patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib treatment in first-line or later line of therapy between January 1, 2018 and September 30, 2020. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talazoparib | Drug | Receipt of talazoparib as treatment for HER2-negative metastatic breast cancer with germline BRCA1/2 mutations anytime between January 1, 2018 and September 30, 2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Failure (TTF) for Talazoparib | TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Participants who were still on therapy at the end of follow-up (earliest of last participant-level structured or abstracted activity [i.e., the last record of participant vitals, medication administrations, or reported laboratory tests/results, or abstracted end date of oral medications] or date of data cut-off [30 September 2020]) were censored. Index date was defined as the date first talazoparib-containing line of therapy between 01-Jan-2018 to 30-Sep-2020. Median was analyzed using the Kaplan-Meier method. | Index date up to talazoparib discontinuation or at the end of follow-up or date of data cut-off (30-September-2020), maximum up to approximately 2.9 years; data retrieved and studied approximately 6.14 months of this study |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria:
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Adult patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib treatment in first-line or later line of therapy between January 1, 2018 and September 30, 2020 identified from Flatiron Health Analytic Database.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Inc. | New York | New York | 10017 | United States |
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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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Data from eligible participants were retrieved and observed in this retrospective chart review study from 17-December-2021 to 30-Jun-2022 (approximately 6.14 months of this study). Data of participants were retrieved from Flatiron Health Analytic Database.
Data of participants diagnosed with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC) germline breast cancer susceptibility gene 1 or gene 2 mutations (gBRCA 1/2m), who initiated treatment with talazoparib on or after 01-Jan-2018 till 30-Sep-2020 (approximately 2.9 years) and were greater than or equal to (>=) 18 years of age during treatment initiation were observed retrospectively in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Talazoparib | Eligible participants who initiated treatment with talazoparib as a first or later line of therapy under real-world routine clinical practice for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Full Analysis Set included adult participants with HER2-negative mBC with gBRCA1/2 mutations who initiated talazoparib treatment in first-line or later identified from Flatiron Health Analytic Database.
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| ID | Title | Description |
|---|---|---|
| BG000 | Talazoparib | Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included. |
| 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 | Time to Treatment Failure (TTF) for Talazoparib | TTF was defined as the time from initiation of talazoparib to discontinuation for any reason, which included disease progression, treatment toxicity, and death. Participants who were still on therapy at the end of follow-up (earliest of last participant-level structured or abstracted activity [i.e., the last record of participant vitals, medication administrations, or reported laboratory tests/results, or abstracted end date of oral medications] or date of data cut-off [30 September 2020]) were censored. Index date was defined as the date first talazoparib-containing line of therapy between 01-Jan-2018 to 30-Sep-2020. Median was analyzed using the Kaplan-Meier method. | Full Analysis Set included adult participants with HER2-negative mBC with gBRCA1/2 mutations who initiated talazoparib treatment in first-line or later identified from Flatiron Health Analytic Database. | Posted | Median | 95% Confidence Interval | Months | Index date up to talazoparib discontinuation or at the end of follow-up or date of data cut-off (30-September-2020), maximum up to approximately 2.9 years; data retrieved and studied approximately 6.14 months of this study |
Not applicable as adverse events were not planned to be collected during the study
Minimum criteria for reporting an adverse event (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not be met. Hence, adverse events were not collected and reported.
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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 | Talazoparib | Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included. |
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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 | Nov 16, 2021 | Jun 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 17, 2021 | Jun 20, 2023 | 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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| ID | Term |
|---|---|
| C586365 | talazoparib |
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|
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Participants According to Subtypes of Breast Cancer | Number of participants with HER2- mBC gBRCA 1/2m were classified according to their sub-types as HR+/HER2- and triple negative breast cancer (TNBC) were reported. | Count of Participants | Participants |
|
| Number of Participants According to gBRCA Mutation Type | Number of participants classified according to gBRCA mutation as breast cancer susceptibility gene 1(BRCA 1), breast cancer susceptibility gene 2 (BRCA 2), breast cancer susceptibility not otherwise specified (BRCA mutation NOS) were reported. | Count of Participants | Participants |
|
| Line of mBC Therapy in Which Talazoparib was Administered | Number of participants were classified according to line of mBC therapy in which talazoparib was initiated were reported. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Talazoparib | Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included. |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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 |