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This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by participating providers from Cardinal Health's Oncology Provider Extended Network (OPEN).
This study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in US.
The primary population for this study includes:
-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary population: Talazoparib-treated patients with HER2- ABC with gBRCA1/2m | HER2-negative ABC patients with gBRCA1/2 mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talazoparib | Drug | This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib. |
| 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. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method. | Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib | rwPFS was defined as the time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurred first. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Since information was retrieved from participants' charts, there was no specific criteria for progression. It was determined on physician judgement. Median was analyzed using the Kaplan-Meier method. |
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Inclusion Criteria:
Diagnosed with HER2-negative ABC
gBRCA1/2 mutation(s)
Treatment with talazoparib monotherapy initiated on or after October 16, 2018
-≥18 years of age at initiation of talazoparib
A minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period
Exclusion Criteria:
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The primary population for this study includes:
-HER2-negative ABC patients with germline BRCA1/2 (gBRCA1/2) mutations treated with talazoparib monotherapy initiated on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
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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 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study). Participants were managed by physicians from Cardinal Health's Oncology Provider Extended Network (OPEN).
Data of participants diagnosed with human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) germline breast cancer susceptibility gene 1 or gene 2 mutations (gBRCA 1/2m), who initiated treatment with talazoparib on or after 16-October-2018 till 11-Oct-2021 (approximately 36 months) 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 for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants with HER2- ABC gBRCA 1/2m who initiated talazoparib on or after 16-October-2018 and were >=18 years of age at initiation of talazoparib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Talazoparib | Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-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. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method. | Analysis population included all eligible participants with HER2- ABC gBRCA 1/2m who initiated talazoparib on or after 16-October-2018 and were >=18 years of age at initiation of talazoparib. Here ''Overall Number of Participants Analyzed'' signifies number of participants with TTF event. | Posted | Median | 95% Confidence Interval | Months | Index date up to talazoparib discontinuation, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
|
All-Cause Mortality: index date up to death due to any cause, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study); since adverse events (AEs) were not collected hence time frame for AEs not applicable
AEs were not collected during the retrospective chart review of this 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 | Talazoparib | Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-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 | Jun 22, 2021 | Oct 7, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2021 | Oct 7, 2022 | 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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|
| Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
| Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy | The time taken for initiating subsequent chemotherapy after initiation of talazoparib was reported in this outcome measure. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method. | Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants According to Molecular Sub-Types of HER2- ABC gBRCA 1/2m | Number of participants with HER2-ABC gBRCA 1/2m were classified according to their molecular sub-types as HR+HER2-ABC gBRCA 1/2m and triple negative breast cancer (TNBC) gBRCA 1/2m. | Count of Participants | Participants |
|
| Line of ABC Therapy in Which Talazoparib was Initiated | The number of participants were classified according to line of ABC therapy in which talazoparib was initiated. | Count of Participants | Participants |
|
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included. |
|
|
| Secondary | Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib | rwPFS was defined as the time from initiation of talazoparib to charted disease progression based on radiographic imaging or death from any cause, whichever occurred first. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Since information was retrieved from participants' charts, there was no specific criteria for progression. It was determined on physician judgement. Median was analyzed using the Kaplan-Meier method. | Analysis population included all eligible participants with HER2- ABC gBRCA 1/2m who initiated talazoparib on or after 16-October-2018 and were >=18 years of age at initiation of talazoparib. Here ''Overall Number of Participants Analyzed'' signifies number of participants with rwPFS event. | Posted | Median | 95% Confidence Interval | Months | Index date up to charted disease progression, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
|
|
|
| Secondary | Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy | The time taken for initiating subsequent chemotherapy after initiation of talazoparib was reported in this outcome measure. Index date was defined as the date of initiation of talazoparib on or after 16-October-2018. Median was analyzed using the Kaplan-Meier method. | Analysis population included all eligible participants with HER2- ABC gBRCA 1/2m who initiated talazoparib on or after 16-October-2018 and were >=18 years of age at initiation of talazoparib. Here ''Overall Number of Participants Analyzed'' signifies number of participants with chemotherapy after talazoparib initiation. | Posted | Median | 95% Confidence Interval | Months | Index date up to initiation of subsequent chemotherapy, from 16-October-2018 maximum up to 11-October-2021 (approximately 36 months); data retrieved and studied from 20-August-2021 to 11-October-2021 (approximately 1.7 months of this study) |
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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 |