Trial Outcomes & Findings for Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m (NCT NCT05141708)
NCT ID: NCT05141708
Last Updated: 2024-02-16
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. 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.
COMPLETED
33 participants
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
2024-02-16
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m
Baseline characteristics by cohort
| Measure |
Talazoparib
n=33 Participants
Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included.
|
|---|---|
|
Age, Continuous
|
53.64 Years
STANDARD_DEVIATION 14.69 • n=99 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown/Undocumented
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
31 Participants
n=99 Participants
|
|
Number of Participants According to Subtypes of Breast Cancer
HR+/HER2 -
|
26 Participants
n=99 Participants
|
|
Number of Participants According to Subtypes of Breast Cancer
TNBC
|
7 Participants
n=99 Participants
|
|
Number of Participants According to gBRCA Mutation Type
BRCA 1 mutation identified
|
11 Participants
n=99 Participants
|
|
Number of Participants According to gBRCA Mutation Type
BRCA 2 mutation identified
|
21 Participants
n=99 Participants
|
|
Number of Participants According to gBRCA Mutation Type
BRCA mutation NOS
|
1 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
First
|
5 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Second
|
6 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Third
|
9 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Fourth
|
3 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Fifth
|
2 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Sixth
|
3 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Seventh
|
2 Participants
n=99 Participants
|
|
Line of mBC Therapy in Which Talazoparib was Administered
Eighth
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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 studyPopulation: 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.
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.
Outcome measures
| Measure |
Talazoparib
n=33 Participants
Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included.
|
|---|---|
|
Time to Treatment Failure (TTF) for Talazoparib
|
5.5 Months
Interval 2.1 to 10.5
|
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