Breast Neoplasms, Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Breast Neoplasms
Brief summary
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.
Interventions
DRUGTalazoparib
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
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
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * Diagnosed with breast cancer (ICD-9 174.x or 175.x or ICD-10 C50x) * At least two visits in the Flatiron database on or after January 1, 2011 * Pathology consistent with breast cancer * Has evidence of stage IV or recurrent metastatic breast cancer with a metastatic diagnosis date on or after January 1, 2011. This includes patients who were diagnosed with stage IV at diagnosis or were diagnosed with earlier stage disease, then developed a distant metastasis later on, or had recurrence of the disease via a distant metastasis * Confirmed receipt of talazoparib as treatment for mBC via abstraction initiated between January 1, 2018 and September 30, 2020 * HER2 negative test result on or before the start of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy rules * BRCA1, BRCA2, BRCA1 and BRCA2 germline mutation, or BRCA germline mutation not otherwise specified, identified on or before the start date of patient's first talazoparib-containing line of therapy, as defined by Flatiron's line of therapy business rules * Age 18 years or older at the time of first talazoparib-containing line of therapy
Exclusion criteria
* Lacking relevant unstructured documents in the Flatiron database for review by the abstraction team * Receipt of drug as part of a clinical trial (captured in the database as clinical study drug without additional information about active ingredient or whether the patient received placebo), defined as any non-cancelled order, administration, or oral episode for a drug used in a clinical trial, on or prior to start of first talazoparib line of therapy, as defined by Flatiron's line of therapy business rules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Failure (TTF) for Talazoparib | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Talazoparib Eligible participants who initiated treatment with talazoparib for HER2- mBC gBRCA 1/2m on or after 01-Jan-2018 were included. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Talazoparib |
|---|---|
| Age, Continuous | 53.64 Years STANDARD_DEVIATION 14.69 |
| Line of mBC Therapy in Which Talazoparib was Administered Eighth | 3 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Fifth | 2 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered First | 5 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Fourth | 3 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Second | 6 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Seventh | 2 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Sixth | 3 Participants |
| Line of mBC Therapy in Which Talazoparib was Administered Third | 9 Participants |
| Number of Participants According to gBRCA Mutation Type BRCA 1 mutation identified | 11 Participants |
| Number of Participants According to gBRCA Mutation Type BRCA 2 mutation identified | 21 Participants |
| Number of Participants According to gBRCA Mutation Type BRCA mutation NOS | 1 Participants |
| Number of Participants According to Subtypes of Breast Cancer HR+/HER2 - | 26 Participants |
| Number of Participants According to Subtypes of Breast Cancer TNBC | 7 Participants |
| Race/Ethnicity, Customized Black | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants |
| Race/Ethnicity, Customized Other | 11 Participants |
| Race/Ethnicity, Customized Unknown | 31 Participants |
| Race/Ethnicity, Customized Unknown/Undocumented | 1 Participants |
| Race/Ethnicity, Customized White | 18 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| 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. 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.
Time frame: 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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Talazoparib | Time to Treatment Failure (TTF) for Talazoparib | 5.5 Months |