Trial Outcomes & Findings for Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer (NCT NCT04987931)
NCT ID: NCT04987931
Last Updated: 2024-01-22
Results Overview
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.
COMPLETED
84 participants
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)
2024-01-22
Participant Flow
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.
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).
Participant milestones
| Measure |
Talazoparib
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included.
|
|---|---|
|
Overall Study
STARTED
|
84
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Talazoparib
n=84 Participants
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included.
|
|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
|
Number of Participants According to Molecular Sub-Types of HER2- ABC gBRCA 1/2m
HR+ HER2- ABC gBRCA1/2 m
|
30 Participants
n=99 Participants
|
|
Number of Participants According to Molecular Sub-Types of HER2- ABC gBRCA 1/2m
TNBC gBRCA 1/2m
|
54 Participants
n=99 Participants
|
|
Line of ABC Therapy in Which Talazoparib was Initiated
First
|
12 Participants
n=99 Participants
|
|
Line of ABC Therapy in Which Talazoparib was Initiated
Second
|
34 Participants
n=99 Participants
|
|
Line of ABC Therapy in Which Talazoparib was Initiated
Third
|
29 Participants
n=99 Participants
|
|
Line of ABC Therapy in Which Talazoparib was Initiated
Fourth
|
9 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Talazoparib
n=52 Participants
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included.
|
|---|---|
|
Time to Treatment Failure (TTF) for Talazoparib
|
8.5 Months
Interval 8.0 to 9.7
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Talazoparib
n=52 Participants
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included.
|
|---|---|
|
Real-World Progression Free Survival (rwPFS) From Initiation of Talazoparib
|
8.7 Months
Interval 8.0 to 9.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Talazoparib
n=21 Participants
Eligible participants who initiated treatment with talazoparib for HER2- ABC gBRCA 1/2m on or after 16-Oct-2018 were included.
|
|---|---|
|
Time From Initiation of Talazoparib to Initiation of Subsequent Chemotherapy
|
12.2 Months
Interval 10.5 to 20.1
|
Adverse Events
Talazoparib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER