Breast Cancer
Conditions
Keywords
Talazoparib, Breast Cancer
Brief summary
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.
Interventions
DRUGTalazoparib
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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* Participation in any BC clinical trial after initiation of talazoparib * Treatment with a PARP inhibitor as neoadjuvant/adjuvant therapy * gBRCA1/2 or HER2 status unknown * Diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure (TTF) for Talazoparib | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib | 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) | 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. |
| Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy | 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) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| Talazoparib Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included. | 84 |
| Total | 84 |
Baseline characteristics
| Characteristic | Talazoparib |
|---|---|
| Age, Continuous | 61.7 Years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 71 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Line of ABC Therapy in Which Talazoparib was Initiated First | 12 Participants |
| Line of ABC Therapy in Which Talazoparib was Initiated Fourth | 9 Participants |
| Line of ABC Therapy in Which Talazoparib was Initiated Second | 34 Participants |
| Line of ABC Therapy in Which Talazoparib was Initiated Third | 29 Participants |
| Number of Participants According to Molecular Sub-Types of HER2- ABC gBRCA 1/2m HR+ HER2- ABC gBRCA1/2 m | 30 Participants |
| Number of Participants According to Molecular Sub-Types of HER2- ABC gBRCA 1/2m TNBC gBRCA 1/2m | 54 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 38 / 84 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Talazoparib | Time to Treatment Failure (TTF) for Talazoparib | 8.5 Months |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Talazoparib | Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib | 8.7 Months |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Talazoparib | Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy | 12.2 Months |